DLT TS CER HD 12/14 36MM +5.0
Report
- Report Number
- 1818910-2016-29275
- Event Type
- Death
- Date Received
- October 12, 2016
- Date of Event
- September 26, 2016
- Report Date
- September 15, 2016
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- LZO
- UDI-DI
- 10603295033660
- PMA / PMN Number
- K071830
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: UDI:(B)(4). CORRECTED:A2.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT#: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). THE INFORMATION ON THIS REPORT SHOULD HAVE SUBMITTED UNDER FOLLOW-UP #3, BUT WAS ERRONEOUSLY SUBMITTED AS FOLLOW-UP #4. THIS REPORT IS BEING ELECTRONICALLY SUBMITTED AT THE REQUEST OF THE FDA TO CORRECT AN ERROR IN THE SEQUENTIAL NUMBERING OF THE FOLLOW-UP REPORTS. DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
COMPLAINT DESCRIPTION: (B)(6) 2016 PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE MEDICAL RECORDS FROM (B)(6) 2016 REPORT THAT THE PATIENT DISLOCATED HER HIP WHEN SHE TOOK A MISSTEP AND THAT THE PATIENT HAS DISLOCATED THREE TIMES SINCE HER REVISION. A RADIOGRAPHY REPORT (B)(6) 2016 REPORTS THAT THE PATIENT FELL. COMPLAINT UPDATED:(B)(6) 2016 / / INVESTIGATION METHOD: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. IN ORDER TO DETERMINE IF A LOT RELATED ISSUE WAS POSSIBLE, A WORLDWIDE COMPLAINT DATABASE SEARCH WAS PERFORMED. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO ADDITIONAL RELATED REPORTS AGAINST THE PROVIDED PRODUCT CODE/LOT CODE COMBINATION(S). BASED ON THE INABILITY TO FIND ANY ADDITIONAL RELATED REPORTS AGAINST THE PROVIDED PRODUCT CODE/LOT CODE COMBINATION(S) IT IS REASONABLE TO CONCLUDE THAT THERE ARE NO ANOMALIES WITH REGARD TO MANUFACTURING OR INSPECTION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. THE REPORTED EVENT IS CONSIDERED ONE OF THE POSSIBLE COMPLICATIONS OF JOINT REPLACEMENT. INVESTIGATIONAL INPUTS WERE REQUESTED AS INDICATED PER INTERNAL PROCEDURES FOR THIS FAILURE MODE. THE COMPLAINT INFORMATION PROVIDED HAS BEEN REVIEWED FOR COMPLAINT CODING, MEDICAL DEVICE REPORTING, AND OTHER DATA REQUIRED BY THE COMPLAINT SYSTEM. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION, IF APPLICABLE, WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A. - WITHOUT THE PHYSICAL COMPLAINT SAMPLE(S) ASSOCIATED WITH THIS REPORT, IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICE(S) FAILED TO MEET SPECIFICATION(S) AT THE TIME IT WAS RELEASED FOR DISTRIBUTION. - THE DEVICE(S) ASSOCIATED WITH THIS EVENT WERE USED IN THE TREATMENT OF THE PATIENT AS PRESCRIBED BY THE PRESIDING SURGEON. - FROM THE EVENT INFORMATION RECEIVED, IT WAS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT. / / INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED.
COMPLAINT DESCRIPTION: 09/15/2016 PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE MEDICAL RECORDS FROM 07/24/2016 REPORT THAT THE PATIENT DISLOCATED HER HIP WHEN SHE TOOK A MISSTEP AND THAT THE PATIENT HAS DISLOCATED THREE TIMES SINCE HER REVISION. A RADIOGRAPHY REPORT 06/01/2016 REPORTS THAT THE PATIENT FELL. COMPLAINT UPDATED:10/12/2016 / / INVESTIGATION METHOD: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. IN ORDER TO DETERMINE IF A LOT RELATED ISSUE WAS POSSIBLE, A WORLDWIDE COMPLAINT DATABASE SEARCH WAS PERFORMED. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO ADDITIONAL RELATED REPORTS AGAINST THE PROVIDED PRODUCT CODE/LOT CODE COMBINATION(S). BASED ON THE INABILITY TO FIND ANY ADDITIONAL RELATED REPORTS AGAINST THE PROVIDED PRODUCT CODE/LOT CODE COMBINATION(S) IT IS REASONABLE TO CONCLUDE THAT THERE ARE NO ANOMALIES WITH REGARD TO MANUFACTURING OR INSPECTION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. THE REPORTED EVENT IS CONSIDERED ONE OF THE POSSIBLE COMPLICATIONS OF JOINT REPLACEMENT. INVESTIGATIONAL INPUTS WERE REQUESTED AS INDICATED PER INTERNAL PROCEDURES FOR THIS FAILURE MODE. THE COMPLAINT INFORMATION PROVIDED HAS BEEN REVIEWED FOR COMPLAINT CODING, MEDICAL DEVICE REPORTING, AND OTHER DATA REQUIRED BY THE COMPLAINT SYSTEM. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION, IF APPLICABLE, WAS CONDUCTED UTILIZING WORK INSTRUCTION (B)(4) APPENDIX A. - WITHOUT THE PHYSICAL COMPLAINT SAMPLE(S) ASSOCIATED WITH THIS REPORT, IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICE(S) FAILED TO MEET SPECIFICATION(S) AT THE TIME IT WAS RELEASED FOR DISTRIBUTION. - THE DEVICE(S) ASSOCIATED WITH THIS EVENT WERE USED IN THE TREATMENT OF THE PATIENT AS PRESCRIBED BY THE PRESIDING SURGEON. - FROM THE EVENT INFORMATION RECEIVED, IT WAS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT. / / INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED.
NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).
ON 09/15/2016 PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE MEDICAL RECORDS FROM (B)(6) 2016 REPORT THAT THE PATIENT DISLOCATED HER HIP WHEN SHE TOOK A MISSTEP AND THAT THE PATIENT HAS DISLOCATED THREE TIMES SINCE HER REVISION. A RADIOGRAPHY REPORT (B)(6) 2016 REPORTS THAT THE PATIENT FELL. COMPLAINT UPDATED: 10/12/2016.
IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALSO ALLEGES PAIN AND EMOTIONAL DISTRESS. AFTER THE REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675336 | DLT TS CER HD 12/14 36MM +5.0 | HEAD | LZO | DEPUY ORTHOPAEDICS INC US | 8223235 | 10603295033660 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Required Intervention |