FDA Adverse Event
Injury
Summary report: N
CONNECTION COMPONENT ROTATIONAL VERSION, SMALL
MDR report key: 12193772
·
Received July 19, 2021
Report
- Report Number
- 3006721341-2021-00004
- Event Type
- Injury
- Date Received
- July 19, 2021
- Date of Event
- June 26, 2021
- Report Date
- June 29, 2021
- Manufacturer
- WALDEMAR LINK GMBH & CO. KG
- Product Code
- KRO
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 2021-06-29, LINKBIO COMPLAINTS DEPARTMENT WAS NOTIFIED OF A REVISION SURGERY THAT TOOK PLACE ON (B)(6) 2021 TO ADDRESS A DISLOCATION OF A FAILED CONNECTION COMPONENT (PART # 16-2840/02, SN # (B)(4)). AS PER THE SALES REPRESENTATIVE, "THE BUSHINGS AND SPRING WERE BEHIND THE IMPLANTS IN THE BACK OF THE JOINT". THIS REPORT CONCERNS THE SAME PATIENT AS REPORT 3006721341-2020-00002 AND 3006721341-2019-00007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1085564 | CONNECTION COMPONENT ROTATIONAL VERSION, SMALL | ROTATING HINGED TOTAL KNEE PROSTHESIS | KRO | WALDEMAR LINK GMBH & CO. KG | 16-2840/02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |