CPCSRecalls & reported problems across all models

We found 19 models of CPCS by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between Mar 11, 2018 and Dec 31, 2025 — classified as 57 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CPCS problems

CPCS models

19 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CPCS 71312372

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  9 reports
• CPCS 71312363

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  8 reports
• CPCS 71312374

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  7 reports
• CPCS 71312362

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  5 reports
• CPCS 71312364

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  5 reports
• CPCS 71312371

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  4 reports
• CPCS 71312410

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  4 reports
• CPCS 71312360

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  3 reports
• CPCS 71312361

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  3 reports
• CPCS 71312370

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  3 reports
• CPCS 71362631

  Prosthesis, hip, femoral component, cemented, metal
  3 reports
• CPCS 71312373

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 reports
• CPCS 71312375

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 reports
• CPCS 71928846

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 reports
• CPCS 71312408

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 report
• CPCS 71312416

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 report
• CPCS 71362704

  Prosthesis, hip, femoral component, cemented, metal
  1 report
• CPCS 71362705

  Prosthesis, hip, femoral component, cemented, metal
  1 report
• CPCS 71363501

  Prosthesis, hip, femoral component, cemented, metal
  1 report

Recent CPCS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Illegible Information; Inaccurate Information; Illegible Information; Inaccurate Information

  IT WAS REPORTED THAT, DURING IMPLANT CEMENTING IN A THR, THE DEPTH MARKINGS ON ONE (1) CPCS COCR PRIM HO 12/14 SZ 4 WERE BARELY VISIBLE, THE SURGEON WAS UNABLE TO LOCATE THE DEPTH MARKS AND SUSPECTS THAT MARKINGS ON THE FADED ETCHINGS ARE ALSO NOT CORRECTLY SPACED. THE SURGEON DID NOT NOTICE THE FADED NATURE OF THE DEPTH MARKINGS UNTIL AFTER THE CEMENT WAS ON FOR 6 MIN AND STEM WAS MOSTLY IN. THE SURGEON SUSPECTS THE STEM MIGHT BE SITTING HIGHER THAN THE TRIAL DUE TO NOT HAVING THE MARKINGS VISIBLE TO REFERENCE CORRECTLY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935121 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A CPCS COCR PRIM SO 12/14 SZ 3, TANDEM INTL BIPOLAR 51OD 28ID AND COCR 12/14 FEM HEAD 28 +0 WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Periprosthetic fracture

  MAUDE report 21469042 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED A PERIPROSTHETIC FRACTURE FOLLOWING A FALL. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE CPCS COCR PRIM HO 12/14 SZ 4, THE TANDEM INTL BIPOLAR 51OD 28ID AND THE COCR 12/14 FEM HEAD 28 +0 WERE EXPLANTED. IN ADDITION, AN EVOS PERIPROSTHETIC PROXIMAL FEMUR PLATE WITH SCREWS AND CABLES WERE USED TO FIX THE FRACTURE. THE PATIENT PASSED AWAY DURING THE RECOVERY PHASE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Periprosthetic fracture

  MAUDE report 21453046 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER HAVING A PRIMARY SURGERY IN WHICH A CPCS STEM WAS IMPLANTED, ONE (1) PATIENT UNDERWENT A REVISION SURGERY DUE TO A PERI-PROSTHETIC FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. THE CURRENT STATE OF HEALTH OF THE PATIENTS IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 20024404 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER HAVING A PRIMARY SURGERY IN WHICH A CPCS STEM WAS IMPLANTED, ONE (1) PATIENT UNDERWENT A REVISION SURGERY DUE TO A PERI-PROSTHETIC FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. THE CURRENT STATE OF HEALTH OF THE PATIENTS IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 20015016 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER HAVING A PRIMARY SURGERY IN WHICH A CPCS STEM WAS IMPLANTED, ONE (1) PATIENT UNDERWENT A REVISION SURGERY DUE TO A PERI-PROSTHETIC FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. THE CURRENT STATE OF HEALTH OF THE PATIENTS IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 20011727 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON A POST-MARKET CLINICAL FOLLOW-UP ACTIVITY FOR CPCS HIP SYSTEMS, IT WAS REPORTED THAT, AFTER UNDERGOING LEFT THR ON (B)(6) 2022 DUE TO AVASCULAR NECROSIS OF THE LEFT FEMORAL HEAD AND LEFT HIP ABDUCTOR TENDON TEAR, ONE (1) PATIENT SUSTAINED A PERIPROSTHETIC FRACTURE OF THE TIP OF THE GREATER TROCHANTER WITH HEMATOMA THAT WAS IDENTIFIED AT 8 WEEKS POSTOPERATIVELY ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING ANY ADDITIONAL INTERVENTION TO TREAT THIS FRACTURE & HEMATOMA.

  Patient problems: Hematoma; Hip Fracture; Pain

  MAUDE report 19972574 ↗
• InjuryJan 18, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR WAS PERFORMED ON (B)(6) 2017, IT WAS NOTICED FROM THE X-RAY ON 23-DEC-2023 THAT THE PATIENT PRESENTED WITH PERI-PROSTHETIC FRACTURE OF THE RIGHT PROXIMAL FEMUR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, IN WHICH A COCR 12/14 FEM HEAD 36MM +4 AND A CPCS COCR PRIM HO 12/14 SZ 2 WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 18540384 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED THAT, DURING A THR ONE (1) CPCS STEM DRIVER BROKE AND DID NOT LOCK INTO DEFINITIVE STEM. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE. NO PIECES FELL INSIDE THE WOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18322372 ↗
• InjuryJul 18, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A THR SURGERY, THE PATIENT EXPERIENCED LOOSENING OF THE CPCS COCR PRIM SO 12/14 SZ 1 STEM. THIS ADVERSE EVENT WAS SOLVED VIA REVISION SURGERY ON (B)(6) 2023, IN WHICH THE STEM, THE LINER AND AN UNKNOWN 28 MM FEMORAL HEAD WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17347703 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE PMCF TITLED DCA-1000 ACCORD SS CLINICAL DATASET, IT WAS REPORTED THAT, AFTER UNDERGOING LEFT HIP HEMIARTHROPLASTY, ONE (1) PATIENT EXPERIENCED DISPLACED FEMORAL NECK FRACTURE. THIS ADVERSE EVENT WAS TREATED BY PERFORMING AN INTERNAL FIXATION SURGERY ON (B)(6) 2021, IN WHICH AN ACCORD CABLE SYSTEM WAS IMPLANTED. A POST-OPERATIVE FOLLOW-UP DETERMINED A GOOD ALIGNMENT WITH NO EVIDENCE OF FRACTURE OR LOOSENING.

  Patient problems: Hip Fracture

  MAUDE report 16583217 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE ASSOCIATED TO THE STEM PROSTHESIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE CPCS COCR PRIM HO 12/14 SZ 3 WAS EXPLANTED. THE PATIENT'S HEALTH STATUS IS NOT KNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT EITHER A REVISION OR RE-REVISION SURGERY WHERE A POLARCUP SHELL WAS PART OF THE HIP CONSTRUCT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE

  Patient problems: Hip Fracture

  MAUDE report 15089980 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR REVISION SURGERY, WHERE A CPCS COCR PRI SO 12/14 SZ 0 WAS IMPLANTED, ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION SURGERY TO EXPLANT FEMORAL STEM DUE TO A PERI-PROSTHETIC FRACTURE ASSOCIATED TO THE FEMUR. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT EITHER A REVISION OR RE-REVISION SURGERY WHERE A POLARCUP SHELL WAS PART OF THE HIP CONSTRUCT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Hip Fracture

  MAUDE report 15089945 ↗
• InjuryJul 22, 2022Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT THR HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED LOOSENING OF THE CPCS COCR PRIM SO 12/14 SZ 2 AND A PERIPROSTHETIC FRACTURE ON THE FEMUR. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2015, WHERE THE FEMORAL STEM, THE FEMORAL HEAD AND THE ACETABULAR LINER WERE EXPLANTED. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT EITHER A REVISION OR RE-REVISION SURGERY WHERE A POLARCUP SHELL WAS PART OF THE HIP CONSTRUCT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Hip Fracture; Inadequate Osseointegration

  MAUDE report 15089940 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA HAD BEEN PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE AROUND THE CPCS COCR PRIM HO 12/14 SZ 2 PROSTHESIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE COMPONENTS FROM THE PROSTHESIS CONSTRUCT WERE EXPLANTED. THE PATIENT'S OUTCOME IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT EITHER A REVISION OR RE-REVISION SURGERY WHERE A POLARCUP SHELL WAS PART OF THE HIP CONSTRUCT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Hip Fracture

  MAUDE report 15089935 ↗

Other Smith & Nephew, Inc. products

• FAST-FIX18 models · 9,554 reports
• JOURNEY566 models · 6,250 reports · 4 recalls
• GENESIS II462 models · 4,599 reports · 2 recalls
• DYONICS, POWERMAX, ELITE2 models · 4,308 reports
• TRIGEN381 models · 3,599 reports · 5 recalls
• LEGION446 models · 2,039 reports · 4 recalls
• REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
• Coblation62 models · 2,126 reports