UNKNOWNARTICULAR SURFACE
Report
- Report Number
- 0001825034-2022-00153
- Event Type
- Injury
- Date Received
- February 7, 2022
- Report Date
- February 7, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JWH
- PMA / PMN Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). WICKER, DANIEL I; GETMAN, GRACE W; CHRISTENSEN, KATHERINE S; CHRISTENSEN, CHRISTIAN P; FULLER, ROBERT M; (2021) A MEDIAL SUBVASTUS APPROACH FOR LATERAL UNICOMPARTMENTAL KNEE ARTHROPLASTY: TECHNIQUE DESCRIPTION AND EARLY OUTCOME RESULTS. ARTHOPLASTY TODAY 9, PG 129-133. HTTPS://WWW.ARTHROPLASTYTODAY.ORG/ARTICLE/S2352-3441(21)00067-4/FULLTEXT. CONCOMITANT MEDICAL PRODUCTS: UNK FIXED LATERAL OXFORD FEMORAL COMPONENT CAT#: NI LOT#: NI, UNK TIBIAL TRAY CAT#: NI LOT#: NI. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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: 0001825034-2022-00151 AND 0001825034-2022-00152.
(B)(4). WICKER, DANIEL I; GETMAN, GRACE W; CHRISTENSEN, KATHERINE S; CHRISTENSEN, CHRISTIAN P; FULLER, ROBERT M; (2021) A MEDIAL SUBVASTUS APPROACH FOR LATERAL UNICOMPARTMENTAL KNEE ARTHROPLASTY: TECHNIQUE DESCRIPTION AND EARLY OUTCOME RESULTS. ARTHOPLASTY TODAY 9, PG 129-133. HTTPS://WWW.ARTHROPLASTYTODAY.ORG/ARTICLE/S2352-3441(21)00067-4/FULLTEXT. CONCOMITANT MEDICAL PRODUCTS: UNK FIXED LATERAL OXFORD FEMORAL COMPONENT CAT#: NI LOT#: NI, UNK TIBIAL TRAY CAT#: NI LOT#: NI. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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: 0001825034-2022-00151 AND 0001825034-2022-00152.
IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE PATIENT WITHIN THE LATERAL APPROACH GROUP WAS REVISED TO A TOTAL KNEE ARTHROPLASTY DUE TO DEEP INFECTION. THE ARTICLE STUDIED OUTCOMES OF LATERAL UKAS FROM A LATERAL VERSUS MEDIAL SUBVASTUS APPROACH. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE PATIENT WITHIN THE LATERAL APPROACH GROUP WAS REVISED TO A TOTAL KNEE ARTHROPLASTY DUE TO DEEP INFECTION. THE ARTICLE STUDIED OUTCOMES OF LATERAL UKAS FROM A LATERAL VERSUS MEDIAL SUBVASTUS APPROACH. 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 |
|---|---|---|---|---|---|---|---|
| 505937 | UNKNOWNARTICULAR SURFACE | PROSTHESIS, KNEE | JWH | ZIMMER BIOMET, INC. | N/A | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization| R |