UNKNOWN STEM
Report
- Report Number
- 0001825034-2018-10193
- Event Type
- Injury
- Date Received
- November 9, 2018
- Report Date
- November 17, 2021
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JDI
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D1; D2; D4; D10 G3; G4; H2; H3; H4; H6 D6: IMPLANT DATE LEFT: (B)(6) 2008 - RIGHT: (B)(6), 2008 D10: 11-163690-32MM M2A HI CARBON HD +6MM NK-985990 11-163688-32MM M2A HI CARBON HD STD NK-544260 10-111152-C2A-T M/H RAD 2HL SHL 41/52MM-949700 10-111152-C2A-T M/H RAD 2HL SHL 41/52MM-919670 15-105044- M2A TPR HI CARBON 41/32MM LNR-473940 15-105044- M2A TPR HI CARBON 41/32MM LNR- 090660 D4 ¿ TWO DEVICE IDS WERE PROVIDED BY THE CUSTOMER/REPORTER; OF THESE, ONLY ONE WAS REVISED. IT IS UNKNOWN WHICH EXACT SIDE/DEVICE ENCOUNTERED THIS ISSUE, IT IS ONE OF THE FOLLOWING: LEFT SIDE: ITEM#: X180311, LOT#: 362280 MANUFACTURE DATE: NOV 1, 2008 STERILE EXPIRY DATE: NOV 30, 2018 510K: K030055, PRO CODE: LPH IMPLANT DATE: (B)(6) 2008 OR RIGHT SIDE: ITEM#: X180310, LOT#: 463480, MANUFACTURE DATE: AUG 1, 2007 STERILE EXPIRY DATE: AUG 31, 2017 510K: K030055, PRO CODE: LPH IMPLANT DATE: (B)(6), 2008 THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D10: G3; H2; H3; H6 D10 CORRECT LOT: C2A-T M/H RAD 2HL SHL 41/52MM - 949670 MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE INITIAL OP RECORDS INDICATED NO COMPLICATIONS. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D10; G3; H2 D10: LEFT SIDE C2A SHELL UPDATED: MANUFACTURING DATE: SEP 30, 2007 EXPIRATION DATE: SEP 30, 2017 D10: RIGHT SIDE C2A SHELL CORRECTED: LOT 949670 UPDATED: MANUFACTURING DATE: SEP 30, 2007 EXPIRATION DATE: SEP 30, 2017
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.
NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.
NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.
NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.
(B)(4). EVENT DATE: (B)(6) 2018. UNKNOWN HEAD ¿ UNKNOWN PART AND LOT. UNKNOWN SHELL ¿ UNKNOWN PART AND LOT. THERAPY DATE: (B)(6) 2018. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 10191. 0001825034 - 2018 - 10192.
IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION DUE TO UNKNOWN REASONS AT AN UNKNOWN AMOUNT OF TIME POST INITIAL IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 894503 | UNKNOWN STEM | PROSTHESIS, HIP | JDI | ZIMMER BIOMET, INC. | N/A | SEE H10 NARRATIVE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Hospitalization| R | . |