SS 12/14 TPR FEM HD 32MM +0
Report
- Report Number
- 1020279-2021-07675
- Event Type
- Death
- Date Received
- October 26, 2021
- Date of Event
- November 6, 2019
- Report Date
- February 7, 2022
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION, BUT THE PICTURES WERE REVIEWED, AND THE REPORTED DISLOCATION WAS CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY EVALUATED AND THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A REVIEW OF THE INSTRUCTION DOCUMENTS CONCLUDED THAT THE INSTRUCTIONS FOR USE OF THE PRODUCT INCLUDES REQUIRED INDICATIONS TO HELP MITIGATE ANTICIPATED ADVERSE EVENTS. A REVIEW OF THE STERILIZATION RECORDS REVEALED THE BATCH WAS STERILIZED WITHIN NORMAL PARAMETERS A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, THE CLINICAL ROOT CAUSE OF THE REPORTED DISLOCATIONS CANNOT BE CONFIRMED. IT CANNOT BE CONCLUDED THE DISLOCATIONS, REDUCTIONS AND SUBSEQUENT REVISION WERE ASSOCIATED WITH A MAL PERFORMANCE OF THE IMPLANT. IT WAS REPORTED THE PATIENT¿S DEATH WAS RELATED TO A DIABETIC FOOT ULCER AND INFECTION. THERE IS NO EVIDENCE THE DIABETES, DIABETIC FOOT ULCER, INFECTION AND SUBSEQUENT DEATH ARE RELATED TO IMPLANT. AT SMITH AND NEPHEW, THE WELLBEING OF OUR CUSTOMERS AS WELL AS THE COMPLIANCE WITH THE AUTHORITIES ARE EXTREMELY IMPORTANT, THEREFORE, OUR DEVICES AND SURGICAL TECHNIQUES ARE SUBJECTED THROUGH NUMEROUS TESTS, VALIDATIONS IN CLINICAL STUDIES AND TRAININGS BEFORE BEING RELEASED TO THE MARKET. HOWEVER, PATIENTS MAY EXPERIENCE ADVERSE EFFECTS AND COMPLICATIONS DEPENDING ON THEIR CONDITION, AGE, PHYSICAL ACTIVITY, AMONG OTHER ASPECTS. DISLOCATION IS A POTENTIAL POSTOPERATIVE COMPLICATION IN HIP SURGERIES. PROBABLE CAUSES FOR THIS INCIDENT COULD INCLUDE BUT ARE NOT LIMITED TO ALIGNMENT, SURGICAL TECHNIQUE, SIZE OF THE DEVICE USED, PATIENT CONDITION OR ABNORMAL LOADING OF LIMB. INFECTION, ALSO A POSSIBLE RISK INVOLVED IN SURGERIES, INCLUDES CONTAMINATION, PATIENT REACTION OR POST-OPERATIVE HEALING ISSUE AS PROBABLE CAUSES. DUE TO THE NEED OF REVISION SURGERIES, THE CONTRIBUTION OF THE DEVICE TO THE REPORTED DISLOCATION WAS CORROBORATED, HOWEVER, THE CONTRIBUTION OF THE DEVICE TO THE REPORTED INFECTION AND DIABETES FOOT ULCER COULD NOT BE CORROBORATED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.
INTERNAL REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT, 3 MONTHS AFTER HAVING A THR, THE PATIENT SUFFERED FROM A DISLOCATION AND UNDERWENT A CLOSED REDUCTION ON (B)(6) 2019. DUE TO ANOTHER DISLOCATION, THE PATIENT HAD AN OPEN REDUCTION ON (B)(6) 2019, WHERE THE FEMORAL HEAD WAS REPLACED. BECAUSE OF THESE PAST RECURRENT DISLOCATIONS BEFORE THE REVISION SURGERY, THE PATIENT HAD TO STAY IN BED FOR ABOUT A YEAR AND DEVELOPED METAL PRESSURE AND DIABETES. AS REPORTED IN THE FINAL OPERATION, THE PATIENT DEVELOPED DIABETIC FOOT ULCER AND PASSED AWAY FROM AN INFECTION ON (B)(6) 2020.
IT WAS REPORTED THAT 3 MONTHS AFTER HAVING A THR, THE PATIENT SUFFERED FROM A DISLOCATION AND UNDERWENT A CLOSED REDUCTION ON (B)(6) 2019. DUE TO ANOTHER DISLOCATION, THE PATIENT HAD AN OPEN REDUCTION ON (B)(6) 2019, WHERE THE FEMORAL HEAD WAS REPLACED. BECAUSE OF THE RECURRENT DISLOCATIONS, THE PATIENT HAD TO STAY IN BED FOR ABOUT A YEAR AND DEVELOPED METAL PRESSURE AND DIABETES. AS REPORTED, THE PATIENT DEVELOPED DIABETIC FOOT ULCER AND PASSED AWAY FROM AN INFECTION ON (B)(6) 2020.
INTERNAL COMPLAINT REFERENCE: (B)(4). POSTAL CODE: (B)(4).
** LEGAL CASE ** IT WAS REPORTED THAT 3 MONTHS AFTER HAVING A THR, THE PATIENT SUFFERED FROM A DISLOCATION AND UNDERWENT A CLOSED REDUCTION ON (B)(6) 2019. DUE TO ANOTHER DISLOCATION, THE PATIENT HAD AN OPEN REDUCTION ON (B)(6) 2019, WHERE THE FEMORAL HEAD WAS REPLACED. AS REPORTED, THE PATIENT UNDERWENT RECURRENT SURGERIES AND DIED FROM POST-SURGICAL INFECTION ON AN UNSPECIFIED DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1596967 | SS 12/14 TPR FEM HD 32MM +0 | PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL | JDG | SMITH & NEPHEW, INC. | 18FT05879 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | Hospitalization| O| D | 71312360-CPCS COCR PRI SO 12/14 SZ 0| 71312360-CPCS COCR PRI SO 12/14 SZ 0| 71312360/CPCS COCR PRI SO 12/14 SZ 0| 71312410 - CPCS DIST CENT SZ 10MM| 71312410/CPCS DIST CENT SZ 10MM| 71332525-REF SPHER HEAD SCREW 25MM| 71332525-REF SPHER HEAD SCREW 25MM| 71332525/REF SPHER HEAD SCREW 25MM| 71332530-REF SPHER HEAD SCREW 30MM| 71332530-REF SPHER HEAD SCREW 30MM| 71332530/REF SPHER HEAD SCREW 30MM| 71335558-R3 3 HOLE ACET SHELL 58MM| 71335558-R3 3 HOLE ACET SHELL 58MM| 71335558/R3 3 HOLE ACET SHELL 58MM| 71339558-R3 0 DEG XLPE ACET LNR 32MM X 58MM| 71339558-R3 0 DEG XLPE ACET LNR 32MM X 58MM| 71339558/R3 0 DEG XLPE ACET LNR 32MM X 58MM| 71312360-CPCS COCR PRI SO 12/14 SZ 0| 71332525-REF SPHER HEAD SCREW 25MM| 71332530-REF SPHER HEAD SCREW 30MM| 71335558-R3 3 HOLE ACET SHELL 58MM| 71339558-R3 0 DEG XLPE ACET LNR 32MM X 58MM |