R3 71337648Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 03596010598479), received between Oct 11, 2017 and Mar 26, 2025 — classified as 14 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (4 reports).

3 other recalls cover devices cleared under the same FDA submission (K113848, K211176); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A THR SURGERY, A R3 20 DEG XLPE ACET LNR 32MM X 48MM DID NOT FIT CORRECTLY INTO THE CUP (IT DID NOT SINK FLUSH WITH THE EDGE). THE PROCEDURE WAS PERFORMED, AFTER SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698375 ↗
• InjuryMay 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM LEFT HIP MECHANICAL LOOSENING AFTER HAVING A THR SURGERY ON (B)(6) 2011. AS NOTED BY THE SURGEON, THE LINER HAS LIKELY SPUN OUT OF THE ACETABULAR COMPONENT. DURING THE REVISION SURGERY PERFORMED ON (B)(6) 2017, THE SURGEON IMPLANTED A BIOMET ACETABULAR SYSTEM AND AN OXINIUM FEMORAL COMPONENT. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 19399042 ↗
• InjuryOct 13, 2023Degraded; Degraded

  IT WAS REPORTED THAT, 1 YEAR AND 8 MONTHS AFTER AN ARTHROSCOPY PERFORMED ON (B)(6) 2022 IN WHICH A R3 SYSTEM WAS IMPLANTED, THE PATIENT SUFFERED FROM EARLY WEAR OF THE POLYETHYLENE INSERT WITH CLINICAL OBSERVATION OF METALLOSIS DUE TO FRICTION IN THE SUBSEQUENT METALLIC COMPONENTS GENERATING COMPLICATIONS AND PIGMENTATION ALTERATIONS AND POSSIBLE INFECTION IN THE TISSUES SURROUNDING THE TREATED AREA. THE PATIENT UNDERWENT A REVISION SURGERY. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED. PATIENT'S HEALTH STATUS IS GOOD.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 17936099 ↗
• MalfunctionAug 10, 2021Loose or Intermittent Connection; Failure to Align; Loose or Intermittent Connection; Failure to Align

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, AN R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 48MM COULD NOT BE LOCKED AND LOOSENED AFTER IMPLANTATION. SURGERY WAS RESUMED, AFTER A SIGNIFICANT DELAY GREATER THAN 30 MIN, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303757 ↗
• InjuryJun 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR ON (B)(6) 2020, A FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO DISLOCATION ((B)(4)). A SECOND HIP REVISION WAS PERFORMED ON (B)(6) 2021 TO REMOVE LINER AND FEMORAL HEAD AS THE PATIENT CONTINUOUSLY DISLOCATED. A NEW FEMORAL HEAD AND +4 LINER WAS IMPLANTED WITH SUCCESS. PATIENT WAS NOT HARMED.

  Patient problems: Joint Dislocation

  MAUDE report 12086312 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. NO OTHER COMPLICATIONS WERE REPORTED. DETAILS ABOUT THE SURGERY, AND IF THE PATIENT RECEIVED ANY MEDICATION TO TREAT THE INFECTION ARE UNKNOWN. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 11922560 ↗
• MalfunctionApr 2, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, THE R3 20 DEG XLPE ACET LNR 32MM X 48MM COULD NOT BE IMPLANTED THEREFORE A SECOND LINER WAS USED. THE PROCEDURE WAS COMPLETED USING A SMITH-NEPHEW BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610712 ↗
• MalfunctionApr 2, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE R3 20 DEGREES XLPE ACET LNEER32MM X 48MM. LINER DID NOT AFFIXED AFTER PLACING. INSTRUMENTS WERE INSIDE THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY OR HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610689 ↗
• MalfunctionMar 23, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A HIP SURGERY, THE INSERT COULDN'T BE IMPLANTED AFTER SEVERAL TIMES. FINALLY A BACKUP CERAMIC INSERT WAS USED TO COMPLETE THE SURGERY. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548609 ↗
• InjuryMar 22, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A THR SURGERY, A R3 20 DEGREES XLPE ACETABULAR LINER 32MM X 48MM COULDN'T BE IMPLANTED INTO THE 48 R3 CUP. FINALLY A 48 CERAMIC INSERT WAS USED TO COMPLETE THE SURGERY. THERE WAS A DELAY LESS THAN OR EQUAL TO 30 MINUTES. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548218 ↗
• InjuryDec 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, THE PATIENT HAS A SPECTRON R3 HIP INSITU AND HAD A HIP REVISION SURGERY DUE TO A DISLOCATION. A NEW R3 20 DEG XLPE ACET LNR 32MM X 48MM WAS IMPLANTED WITH SUCCESS. PATIENT CURRENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Dislocation

  MAUDE report 11038649 ↗
• MalfunctionSep 18, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY, R3 CUP WAS IMPLANTED BY THE DOCTORS. THE DOCTORS WERE ABOUT TO INSTALL THE LINER. BUT THE DIFFICULTIES AROSE WITH THE INSERT INSTALLING . IT WAS POSSIBLE TO INSTALL IT ONLY ON THE 10TH TRY. THE DOCTORS CLEANED THE WOUND REPEATEDLY, CHECKED THE CUP FOR POSSIBLE PARTICLES PRESENCE OBSTRUCTING THE IMPLANTATION. NOTHING INTERFERED WITH THE IMPLANTATION OF THE LINER. THERE WAS A DELAY GREATER THAT 30 MINUTES REPORTED. THERE WAS NO INJURY REPORTED. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10555492 ↗
• MalfunctionSep 4, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A THR PROCEDURE THE R3 20 DEG XLPE ACET LNR 32MM X 48MM WAS LOOSE AFTER IMPLANTING THE INSERT AND IT COULD NOT BE FIRMLY LOCKED. A DELAY OF LESS THAN 30 MIN WAS REPORTED. S&N BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO INJURIES REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10492298 ↗
• MalfunctionSep 2, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE FINAL IMPLANT LINER WAS NOT SITTING PROPERLY ON THE CUP. THERE WERE ISSUES WITH THE LOCKING. NO DELAY. IT IS UNKNOWN WHEN THE EVENT OCCURS AND IF THERE WAS A BACKUP AVAILABLE. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10486335 ↗
• MalfunctionAug 18, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING THR SURGERY, THE CUP DID NOT MATCH IN THE LINER. THE PROCEDURE WAS COMPLETED WITHOUT DELAY AND BACKUP FROM SMITH&NEPHEW WAS AVAILABLE TO FINISHED THE PROCEDURE. PATIENT INJURIES WERE NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10422770 ↗
• InjuryJul 11, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A REVISION SURGERY HAD TO BE PERFORMED DUE TO PAIN, SWELLING AND DISLOCATION. THIS CASE IS NOT CAUSED BY S+N DEVICES DEFECT. SURGEON DOES NOT FAULT THE DEVICES.

  Patient problems: Injury; Pain

  MAUDE report 10261755 ↗
• InjuryJun 18, 2020Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem

  IT WAS REPORTED THAT DURING A THA SURGERY, AFTER IMPLANTING THE R3 OUTER CUP, THE 32MM X 48MM R3 20 DEGREE XLPE ACETABULAR LINER COULD NOT BE IMPLANTED. THE PROCEDURE WAS CONCLUDED WITH A 50 MM LINER FROM SMITH AND NEPHEW. SURGERY WAS DELAYED LESS THAN 30 MIN. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10171115 ↗
• InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INITIAL THR TOOK PLACE ON (B)(6) 2020. WASHOUT PERFORMED AND LINER AND HEAD REMOVED AND REPLACED DUE TO INFECTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10012019 ↗
• InjuryApr 15, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY AFTER THE CUP WAS IMPLANTED, A 48/32 LINER WAS NOT FITTING WITH A 48/32 CUP (SMALLER). A BACKUP LINER WAS USED ALONG WITH ADDITIONAL BONE CUTS IN ORDER TO COMPLETE THE SURGERY. NO WAS DELAY REPORTED.

  Patient problems: Injury

  MAUDE report 9965191 ↗
• InjuryDec 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. AFTER THE TOTAL HIP REPLACEMENT, THE POST-OP X-RAYS SHOWED THAT THE LINER DIDN'T ENGAGE/ LOCK INTO THE CUP, IT MUST HAVE ¿POPPED¿ OUT. EXPLANTED DEVICES: LINER, DUE TO EXTENSIVE DAMAGED AND THE BALL HEAD AS IT WAS MOVING ON THE RIM OF THE CUP, ALSO DAMAGING IT.

  Patient problems: Injury

  MAUDE report 9530077 ↗
• InjuryJul 31, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY POST FALL AND CUP, LINER AND FEMORAL HEAD WERE REMOVED. NO OTHER MEDICAL INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8845139 ↗
• InjuryNov 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED DUE TO INFECTION. THE HEAD AND THE LINER WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 7028071 ↗
• InjuryOct 11, 2017Migration or Expulsion of Device

  IT WAS REPORTED THAT THE DOCTOR REVISED THE ACETABULAR SHELL ON THE PATIENT. IT WAS REMOVED THE LINER, HOLE COVER, SHELL AND FEMORAL HEAD. THE PATIENT HAD POOR BONE STOCK AND THE CUP SHIFTED.

  Patient problems: No Code Available

  MAUDE report 6942456 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113848, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
• Z-1928-2013 · May 29, 2013 · Terminated
  R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.
• Z-1929-2013 · May 29, 2013 · Terminated
  R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.