ZIMMER MMC CUP, UNCEMENTED, 56 MM/48 MM, CODE N
Report
- Report Number
- 0009613350-2020-00577
- Event Type
- Injury
- Date Received
- December 10, 2020
- Report Date
- November 8, 2021
- Manufacturer
- ZIMMER SWITZERLAND MANUFACTURING GMBH
- Product Code
- KWA
- PMA / PMN Number
- K091003
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION WHICH WAS RECEIVED ON JAN 09, 2021. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE OR AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THIS MDR FU IS BEING SENT TO REPORT THAT DURING THE INVESTIGATION OF THIS COMPLAINT, IT WAS FOUND THAT ZIMMER INC MODULAR STEM 00-7713-012-00 IS THE MAIN PRODUCT IN THIS EVENT. THEREFORE, PLEASE INVALIDATE THIS MEDWATCH FROM YOUR SYSTEM. THE CASE WILL BE FURTHER REPORTED BY ZIMMER INC. AND THE ZIMMER MMC, CUP, UNCEMENTED, 56 MM/48 MM, CODE N; ITEM NUMBER: 0100634056; LOT NUMBER UNKNOWN REPORTED AS ASSOCIATED DEVICE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WINTERTHUR AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES. ADDITIONAL INFORMATION WAS RECEIVED ON FEB 08, 2021. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. ADDITIONAL: A2, B5, D1, D2, D4, D6, D10, G4, H6.. CORRECTION: B4, D3, D8, E1, G1-2, G3, G6, H10. D10: MEDICAL PRODUCTS: KIN POR ST-NK, 40MM MET LDH; CATALOG#: 98000131503; LOT#: UNKNOWN MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 12.5 CATALOG#: 00-7713-012-00; LOT#: UNKNOWN. MODULAR NECK R2 12/14 NECK TAPER USE WITH +0 HEADS ONLY. CATALOG#: 00-7848-042-01; LOT#: UNKNOWN. METASUL LDH HEAD ADAPTER, M, 0, TAPER 12/14-18/20; CATALOG#: 01.00185.146; LOT#: UNKNOWN. METASUL LDH HEAD, 48, CODE N, TAPER 18/20; CATALOG#: 01.00181.480; LOT#: UNKNOWN. THERAPY DATE: (B)(6) 2020. THE MANUFACTURER RECEIVED X-RAY AND OTHER SOURCE DOCUMENTS FOR REVIEW. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
PATIENT WAS IMPLANTED WITH A DUROM CUP ON AN UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO FRACTURE AROUND THE FEMORAL COMPONENT.
DURING INVESTIGATION IT WAS FOUND THAT ZIMMER INC. MODULAR STEM 00-7713-012-00 IS THE MAIN PRODUCT IN THIS COMPLAINT. THEREFORE, THIS MDR FU IS BEING SENT TO REMOVE THE MMC CUP AS MAIN PRODUCT IN THIS COMPLAINT AND ADD IT AS ASSOCIATED.
PATIENT WAS IMPLANTED A ZIMMER MMC CUP ON AN UNKNOWN SIDE AND UNDERWENT A REVISION SURGERY DUE TO FRACTURE AROUND THE FEMORAL COMPONENT. THERE WAS NO INFECTION.
THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. WHILE A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008 AS REFERENCED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BECOMES AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
PATIENT WAS IMPLANTED WITH A DUROM CUP ON AN UNKNOWN DATE AND IS SCHEDULED FOR A REVISION SURGERY ON AN UNKNOWN DATE DUE TO UNKNOWN REASONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1453032 | ZIMMER MMC CUP, UNCEMENTED, 56 MM/48 MM, CODE N | ZIMMER MMC CUP | KWA | ZIMMER SWITZERLAND MANUFACTURING GMBH | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization | SEE H10 NARRATIVE |