SIGMA 94-0023Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295223474), received between Nov 20, 2017 and Oct 30, 2025 — classified as 23 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED KNEE. IMPLANTS WERE REMOVED AND CEMENT SPACER WAS IMPLANTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23423493 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH SOME PAIN IN HER KNEE. SURGEON BELIEVES THE PATIENT TO BE INFECTED BUT ONLY SUPERFICIAL. UPON OPENING THE JOINT, THA TIBIA WAS FOUND TO BE LOOSE. SURGEON REMOVED ALL IMPLANTS AND PLACED A SPACER USING AN ATTUNE RPPS POLY AND CEMENTED ATTUNE PS FEMUR UNTIL THE INFECTION CLEARS AND SURGEON CAN COME BACK TO REVISE. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22116174 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS: CLINICAL ADVERSE EVENTS RECEIVED FOR CONTINUED PAIN, PINCHING SENSATION. DEVICE AND PROCEDURE(RELATEDNESS). DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: REMOTE POSSIBILITY. DATE OF EVENT: 8/OCT/2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: SURGICAL EXPLORATION OF THE FEMUR AND DEBRIDEMENT OF THE FAT PAD. DEPUY COMPONENTS USED IN PROCEDURE WITHOUT DATE OF REVISION: CATALOG ID: 129433130, LOT ID: 9744770, COMPONENT TYPE: TIBIAL, DESCRIPTION: MBT CEMENTED KEEL SZ 3. CATALOG ID: 940023, LOT ID: J50C75, COMPONENT TYPE: FEMORAL, DESCRIPTION: SIGMA FEM C/RET POROCOAT SZ 3 RT. CATALOG ID: 960101, LOT ID: D20101506, COMPONENT TYPE: PATELLAR, DESCRIPTION: SIGMA PATELLA OVAL DOME 3 PEGGED 35MM. CATALOG ID: 3322020, LOT ID: 9524034, COMPONENT TYPE: CEMENT, DESCRIPTION: SMART SET BONE CEMENT 20G. CATALOG ID: 3322020, LOT ID: 9448053, COMPONENT TYPE: CEMENT, DESCRIPTION: SMART SET BONE CEMENT 20G. CATALOG ID: 196192034, LOT ID: 9137529, COMPONENT TYPE: INSERT, DESCRIPTION: AOX CVD RP TIBIAL INSERT SZ 3 17.5MM. THE PATIENT STATUS POST: RIGHT KNEE REPLACEMENT/REVISION KNEE REP

  Patient problems: Discomfort; Numbness; Pain; Paresthesia

  MAUDE report 20558629 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(4). CLINICAL ADVERSE EVENTS RECEIVED FOR RUPTURE OF HER PATELLAR TENDON REPAIR. NO IMPLANT OR EXPLANT DATES KNOWN. ISSUE OCCURRED ON RIGHT SIDE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20521202 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR GI BLEED. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2024. (RIGHT KNEE). TREATMENT: FOUR UNITS OF BLOOD.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19142605 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR PATELLAR TENDON INJURY (EXTENSOR MECHANISM INSUFFICIENCY). EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023 DATE OF EVENT: (B)(6) 2024 (RIGHT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19032552 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2022: PATIENT RECEIVED A RIGHT KNEE I&D AND PRIMARY POLY SWAP TO TREAT HEMATOGENOUS SEPSIS. THE PATIENT WAS REVISED WITH AN UNKNOWN INSERT. THIS EVENT WAS NOTED AS PART OF THE PATIENT¿S MEDICAL HISTORY. THIS IS A PREVIOUSLY UNKNOWN COMPLAINT AND THERE ARE NO MEDICAL RECORDS AVAILABLE FOR THIS EVENT. ON (B)(6) 2023: A 63-YEAR-OLD FEMALE PATIENT RECEIVED A RIGHT KNEE STAGE ONE REVISION TO TREAT PAIN, SWELLING, AND DISCOMFORT SECONDARY TO ACUTE SEPSIS/GROSS INFECTION. THE SURGEON SPECIFICALLY NOTES THIS INFECTION WAS NOT RECURRENT. UPON ENTERING THE JOINT, GROSS PUSS WAS EVACUATED AND TWO CAPSULAR TEARS WERE IDENTIFIED. EXTENSOR MECHANISM ALLOGRAFT WAS COMPLETELY AVASCULAR. A SCAR TISSUE DEBRIDEMENT WAS PERFORMED. THERE WAS MILD-TO-MODERATE BONE LOSS OF THE TIBIAL AND FEMUR. ALL COMPONENTS WERE REVISED AND THE EXTENSOR MECHANISM ALLOGRAFT FROM THE PREVIOUS REPAIR WAS DEBRIDED. A COMPETITOR SPACER WAS INSERTED, AND THE CAPSULAR TEARS WERE REPAIRED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: ON (B)(6) 2021, DOE: ON (B)(6) 2022 PATELLA FRACTURE REPAIR (B)(4), ,DOE: ON (B)(6) 2022: CERCLAGE REMOVAL, I&D, AND EXTENSOR MECHANISM REPAIR (B)(4)

  Patient problems: Adhesion(s); Discomfort; Pain; Sepsis; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18941425 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION, DOCTOR PULLED THE IMPLANTS AND PUT IN A SPACER. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18382737 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. THE PATELLA WAS AN IMPLANT. IT WAS LEFT UNTOUCHED. AND WAS DONE BY THE FIRST IMPLANTATION IN 2011. NO SURGICAL DELAYS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17423649 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR CONTINUED WOUND DRAINAGE. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: WOUND VAC PLACEMENT.

  Patient problems: Fluid Discharge

  MAUDE report 14437906 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTES (B)(6) 2022 INDICATE THE PATIENT EXPERIENCED AN INFERIOR POLE PATELLA FRACTURE/PATELLAR TENDON COMPROMISE. DUE TO THIS, THE PATIENT RECEIVED A REPAIR INFERIOR POLE OF THE PATELLA FRACTURE AND PATELLAR TENDON DEFICIENCY AND AUGMENTATION OF REPAIR WITH FRESH FROZEN ACHILLES ALLOGRAFT. REPAIR WAS PERFORMED IN PART BY USING #5 TI-CRON WIRE STITCH. (CAPTURED ON (B)(4)). OPERATIVE NOTES (B)(6) 2022 INDICATE THE PATIENT EXPERIENCED A RETAINED BROKEN TENSION BAND WIRE (TI-CRON) IN THE RIGHT KNEE, STATUS POST EXTENSOR MECHANISM RECONSTRUCTION AND DELAYED AND NON-HEALING WOUND FROM THE REPAIR SURGICAL PROCEDURE. DUE TO THIS, THE PATIENT RECEIVED A SURGICAL REMOVAL OF TENSION BAND WIRE, EXCISION OF NONHEALING WOUND, 7 CM WITH A PRIMARY SUTURE REPAIR AND PLACEMENT OF A LONG LEG CAST. NO IMPLANTS WERE REVISED, COPIOUS IRRIGATION WAS PERFORMED. NO INDICATION OF COMPLICATIONS.

  Patient problems: Pain; Swelling/ Edema; Unspecified Musculoskeletal problem

  MAUDE report 13890372 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BROKEN WIRE AND THIS IS INCREASINGLY CAUSING PAIN. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2021; DATE OF EVENT: (B)(6) 2022; (RIGHT KNEE). TREATMENT: A SURGICAL REMOVAL OF TENSION BAND WIRE, EXCISION OF NONHEALING WOUND, 7 CM WITH A PRIMARY SUTURE REPAIR AND PLACEMENT OF A LONG LEG CAST.

  Patient problems: Impaired Healing; Pain; Unspecified Tissue Injury

  MAUDE report 13860788 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR OCCASIONAL PAIN, POSSIBLE SYNOVIAL PINCHING OR REGROWTH OF FAT PAD. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: ARTHROSCOPY.

  Patient problems: Pain

  MAUDE report 13824056 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES ON (B)(6) 2009, INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. OFFICE NOTES ON (B)(6) 2021, INDICATE THE PATIENT IS EXPERIENCING PAIN AND SWELLING OF THE RIGHT KNEE IN ADDITION TO THE PREVIOUSLY NOTED AE. NO ADDITIONAL TREATMENT PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema

  MAUDE report 12908031 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE INDOLENT INFECTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: INVASIVE MEDICAL INTERVENTION - KNEE ASPIRATION: 15 CCC CLOUDY YELLOW FLUID SENT FOR SYNOVASURE. DEPUY COMPONENTS: CATALOG ID: 960102, LOT ID: D20111528, DESCRIPTION: OVAL DOME PATELLA 3 PEG SZ 38. CATALOG ID: 129433130, LOT ID: 9574594, DESCRIPTION: MBT CEMENTED KEEL SZ 3. CATALOG ID: 196192032, LOT ID: 9677217, DESCRIPTION: AOX CVD RP TIBIAL INSERT SZ 3 12.5MM. CATALOG ID: 940023, LOT ID: J56W17, DESCRIPTION: SIGMA FEM C/RET POROCOAT SZ 3 RT. CATALOG ID: 3322020, LOT ID: 9448053, DESCRIPTION: SMART SET BONE CEMENT 20G. CATALOG ID: 3322020, LOT ID: 9448053, DESCRIPTION: SMART SET BONE CEMENT 20G.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 12689216 ↗
• MalfunctionFeb 22, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  STUDY: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS PROBABLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019. (RIGHT KNEE) TREATMENT: NONE. FURTHER INFORMATION PROVIDED: ON (B)(6) 2019, THE PATIENT PRESENTED FOR A BILATERAL KNEE EVALUATION FIVE MONTHS POST-OPERATIVELY. INVOLVING THE RIGHT KNEE, THE PATIENT WAS EXPERIENCING INSTABILITY, LOCKING/STIFFNESS EXPERIENCED AT NIGHT THAT WOULD SUBSIDE, MILD PAIN ALONG WITH LOCKING, MILD EFFUSION, AND A AUDIBLE CLUNK PRODUCED THROUGH PALPATION BY THE PHYSICIAN. THERE IS NO EVIDENCE OF REVISION NOR INVASIVE TREATMENT INVOLVING THE RIGHT KNEE.

  Patient problems: Joint Laxity; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 11359094 ↗
• InjuryOct 7, 2020Loss of Osseointegration; Loss of Osseointegration

  (B)(6). THIS COMPLAINT IS TO CAPTURE THE REVISION SURGERY REPORTED IN (B)(4). ON (B)(6) 2019 THE PATIENT HAD A REVISION OF THE RIGHT TOTAL KNEE DUE TO RIGHT KNEE INSTABILITY WITH ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND PAIN. COMPETITOR CEMENT WAS NOTED TO BE USED DURING THE REVISION. DURING THE SURGERY, THERE WAS LYSIS AT THE LATERAL FEMORAL CONDYLE. DOI: (B)(6) 2011; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available; Osteolysis; Pain

  MAUDE report 10643662 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AS PER SURGEON, THE PATIENT WAS EXPERIENCING FLEXION INSTABILITY. UNKNOWN IF ORIGINAL CASE OCCURRED AT(B)(6) BUT THEIR OFFICE WAS ABLE TO TRACE THE LOT NUMBER FROM THE FEMUR TO THAT FACILITY AND DATE. THEY DO NOT HAVE PART NUMBER ON INSERT BUT KNOW IT WAS A SIGMA CR AOX SZ 15MM AND POTENTIAL LOT NUMBER IS 3472040. PATELLA ALSO RETAINED BUT NO PART NUMBERS. SURGEON REMOVED FEMUR, TIBIA, INSERT, AND REVISED TO ATTUNE REVISION. DOI: (B)(6) 2011, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10305438 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10167375 ↗
• InjuryMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY TOTAL KNEE REPLACEMENT ON (B)(6) 2013 WHERE A PFC SIGMA WAS UTILIZED. PATIENT HAS REPORTED THAT SHE NEVER FELT COMFORTABLE AND THAT IT WAS NOT LONG AFTER THE PRIMARY TKR THAT SHE BEGAN TO EXPERIENCE ANTERIOR KNEE PAIN. X RAYS OF THE KNEE APPEAR TO BE ACCEPTABLE, THE PATELLA APPEARS TO BE A PATELLA BAHA. A DECISION WAS MADE TO REVISE THE COMPONENTS AND IMPLANT AN ATTUNE REVISION SYSTEM. ON OPENING THE KNEE, ALL COMPONENTS APPEARED TO BE WELL FIXED. THE FEMORAL AND TIBIAL COMPONENTS WERE REMOVED AND THE PATELLA LEFT IN SITU. THE TIBIA WAS DISTALIZED AND THE FEMUR SUBSEQUENTLY BALANCED BY DISTALIZED AND UP SIZING.

  Patient problems: No Code Available; Pain

  MAUDE report 10075116 ↗
• MalfunctionFeb 14, 2020Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE). TREATMENT: NONE - AWAITING REVISION OF THE KNEE/PLAN TO REVISE THE TIBIAL INSERT ONLY.

  Patient problems: Adhesion(s)

  MAUDE report 9714647 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - DVT : CLOTS IN PERONEAL VESSELS, AS WELL AS THE POSTERIOR TIBIAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT: (B)(6) 2019, (RIGHT KNEE).

  Patient problems: Thrombosis

  MAUDE report 9008612 ↗
• InjuryDec 10, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE POROUS COATING WAS OUT OF TOLERANCE AND RESULTED IN AN UNSATISFACTORY SCRATCH FIT. THERE WAS ALSO LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: Not Applicable

  MAUDE report 8146443 ↗
• InjuryFeb 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION TKR, (B)(6) PRIVATE HOSPITAL (B)(6) 2018. PATIENT UNDERWENT PRIMARY TKR ON (B)(6) 2011. PATIENT HAS BEEN DOING WELL UNTIL APPROXIMATELY 9 MONTHS AGO WHERE THE KNEE HAS BECOME BOTH PROGRESSIVELY PAINFUL AS WELL AS PROGRESSIVELY STIFF. PATIENT WAS ACHIEVING APPROXIMATELY 45 DEGREES OF FLEXION 6 MONTHS AGO AND AT TIME OF SURGERY WAS ONLY ACHIEVING APPROXIMATELY 30 DEGREES FLEXION. ON OPENING THE KNEE, BOTH THE TIBIAL AND FEMORAL IMPLANTS APPEARED WELL FIXED. SCAR TISSUE WAS PRESENT IN THE INTER CONDYLAR NOTCH. THE KNEE WAS REMOVED AND A PFC TC3 IMPLANTED. PATIENT WAS ACHIEVING APPROXIMATELY 110 DEGREES ON THE TABLE. DOI: (B)(6) 2011;DOR: (B)(6) 2018; UNKNOWN AFFECTED SIDE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 7247139 ↗
• InjuryNov 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE CEMENTLESS CR SIZE 3 SIGMA WAS HOT ON ONE SCAN AND WAS THOUGHT TO BE LOOSE AND THE REASON FOR PAIN.

  Patient problems: Pain

  MAUDE report 7044660 ↗