M2A 38MM MOD HD -6MM NK
Report
- Report Number
- 0001825034-2020-02695
- Event Type
- Injury
- Date Received
- July 10, 2020
- Date of Event
- June 22, 2020
- Report Date
- March 29, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LZO
- PMA / PMN Number
- K062997
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11: TAPERLOC FEMORAL POROUS COATED 103201 LOT# 931140. M2A 38MM X48 RD118848 LOT#982610. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS AND COMPLAINT SAMPLE EVALUATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. AN M2A 38MM MOD HD -6MM NK, PART # 11-173660 FROM LOT 521480, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND DINGS ON THE RIM OF THE HEAD. DARK DEBRIS IS PRESENT INSIDE THE TAPER. THE OUTER RADIUS IS SCRATCHED AND COVERED IN A DRIED LIGHT COLORED FILM. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS INDICATE THAT THE PATIENT UNDERWENT AN INITIAL LEFT THA DUE TO OSTEOARTHRITIS; NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. PATIENT WAS REVISED DUE TO AN IDENTIFIED MASS. PATIENT DEVELOPED SWELLING AND LARGE SOFT TISSUE TUMOR CREATING VASCULAR COMPROMISE AND VENOUS THROMBOSIS REMOVED 3 MONTHS PRIOR BY VASCULAR SURGERY TEAM. STEM AND CUP WERE WELL FIXED; ELECTED NOT TO REVISE HOWEVER OSTEOLYTIC REGRESSION OF SUPPORTIVE BONE OF BOTH IMPLANTS. NO ABNORMAL FINDINGS OF TRUNNION AND ARTICULAR SURFACE. PSEUDOCAPSULE NOTED POSTERIORLY, DENSE FIBROUS TISSUE EXCISED AND SENT TO PATHOLOGY. HEAD WAS EXPLANTED AND REPLACED WITH DUAL ARTICULATION. NO INTRAOPERATIVE COMPLICATIONS NOTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY SEVENTEEN YEARS POST IMPLANTATION DUE TO A PSUEDOTUMOR, SWELLING, ALTR, DVT, AND OSTEOLYSIS. DURING THE PROCEDURE HEAD, CUP AND STEM COMPONENTS WERE REMOVED AND REPLACED WITH A DUAL MOBILITY SYSTEM. NO ADDITIONAL INFORMATION IS AVAILABLE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). IMPLANT DATE: (B)(6) 2003. CONCOMITANT MEDICAL DEVICES: ITEM #: UNKNOWN, UNKNOWN STEM, LOT #: UNKNOWN; ITEM #: UNKNOWN, UNKNOWN CUP, LOT #: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT WAS RETURNED TO THE CUSTOMER AND THE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 02696 CUP, 0001825034 - 2020 - 02697 STEM.
IT WAS REPORTED PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY SEVENTEEN YEARS POST IMPLANTATION DUE TO A MASS. DURING THE PROCEDURE HEAD, CUP AND STEM COMPONENTS WERE REMOVED AND REPLACED WITH A DUAL MOBILITY SYSTEM. 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 |
|---|---|---|---|---|---|---|---|
| 724071 | M2A 38MM MOD HD -6MM NK | PROSTHESIS, HIP | LZO | ZIMMER BIOMET, INC. | N/A | 521480 | |
| 724072 | M2A 38MM MOD HD -6MM NK | PROSTHESIS, HIP | LZO | ZIMMER BIOMET, INC. | N/A | 521480 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Hospitalization| R | SEE H10| SEE H10 |