AS COLUMBUS REV F TIB.OFFSET CEMENT.T2+
Report
- Report Number
- 9610612-2023-00055
- Event Type
- Injury
- Date Received
- March 20, 2023
- Date of Event
- May 18, 2020
- Report Date
- July 22, 2023
- Manufacturer
- AESCULAP AG
- Product Code
- JWH
- PMA / PMN Number
- K083772
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
ADDITIONAL INFORMATION: H6 - CODES UPDATED. INVESTIGATION: DUE TO THE CIRCUMSTANCE THAT NO PRODUCT WAS PROVIDED AN INVESTIGATION IS NOT POSSIBLE. REVIEW OF BATCH HISTORY RECORDS: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE DUE TO THE CIRCUMSTANCE THAT THE ROOT CAUSE FOR THE LOOSENING COULD NOT BE CLEARLY DETERMINED THE PRA IS ONLY CONDITIONALLY APPLICABLE; SEVERITY IS 4(5) AND PROBABILTY 2(5). EXPLANATION AND RATIONALE: ON THE BASIS OF THE CURRENT INFORMATION AND WITHOUT THE PRODUCT FOR INVESTIGATION, A CLEAR CONCLUSION REGARDING THE IMPLANT LOOSENING CANNOT BE DRAWN. THERE ARE SEVERAL AND OFTEN COMPLEX ROOT CAUSES FOR AN IMPLANT LOOSENING: POSSIBLY DUE TO SEPTIC CONDITIONS OR, FOR EXAMPLE, TO INCORRECT LOADING, TOO EARLY OR TOO HIGH LOADING, WHICH MAY ALSO HAVE OCCURRED LONG BEFORE THE ONSET OF LOOSENING, SUBOPTIMAL POSITIONING (DUE TO THE PATIENT), INAPPROPRIATE CHOICE OF IMPLANT, INAPPROPRIATE SURGICAL PROCEDURE OR INAPPROPRIATE CEMENTING TECHNIQUE, AND MANY OTHERS. CONCLUSION AND PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, THE ROOT CAUSE CANNOT BE CLEARLY DETERMINED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NR074Z - AS COLUMBUS REV F TIB. OFFSET CEMENT. T2+. ACCORDING TO THE COMPLAINT DESCRIPTION, THE REVISION SURGERY WITH COLUMBUS IMPLANTS WAS PERFORMED DUE TO ASEPTIC LOOSENING. A RE-REVISION SURGERY WAS PERFORMED DUE TO THE REPEATED LOOSENING. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE: (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2023-00054 (400591991 - NR004Z). INVOLVED COMPONENTS: NR574Z - AS COLUMBUS REV FEM. SPACER POST. F4 10MM - LOT UNKNOWN. NR464Z - AS COLUMBUS REV FEM. SPACER DIST. F4 5MM - LOT UNKNOWN. NR180Z - AS TIBIA OFFSET STEM D20X92 CEMENTLESS - LOT UNKNOWN. NR622M - COLUMBUS REV F HC GLID. SURF. T2/2+ 14MM - LOT UNKNOWN. NX043 - PATELLA 3-PEGS P3 - LOT UNKNOWN. AE-QAS-K521-53 - COLLECT. NO. QAS KNEE IMPLANTS COLUMBUS - LOT UNKNOWN.
ASSOCIATED MEDWATCH-REPORTS: 9610612-2023-00054 ((B)(4) - NR004Z). 9610612-2023-00055 ((B)(4) - NR074Z). INVOLVED COMPONENTS: NR574Z - AS COLUMBUS REV FEM.SPACER POST.F4 10MM - LOT UNKNOWN. NR464Z - AS COLUMBUS REV FEM.SPACER DIST.F4 5MM - LOT UNKNOWN. NR180Z - AS TIBIA OFFSET STEM D20X92 CEMENTLESS - LOT UNKNOWN. NR622M - COLUMBUS REV F HC GLID.SURF.T2/2+ 14MM - LOT UNKNOWN. NX043 - PATELLA 3-PEGS P3 - LOT UNKNOWN. AE-QAS-K521-53 - COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS - LOT UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1767465 | AS COLUMBUS REV F TIB.OFFSET CEMENT.T2+ | KNEE ENDOPROSTHETICS | JWH | AESCULAP AG | NR074Z |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Required Intervention | AE-QAS-K521-53 - LOT UNKNOWN| AE-QAS-K521-53 - LOT UNKNOWN| NR180Z - LOT UNKNOWN| NR180Z - LOT UNKNOWN| NR464Z - LOT UNKNOWN| NR464Z - LOT UNKNOWN| NR574Z - LOT UNKNOWN| NR574Z - LOT UNKNOWN| NR622M - LOT UNKNOWN| NR622M - LOT UNKNOWN| NX043 - LOT UNKNOWN| NX043 - LOT UNKNOWN |