FDA Adverse Event
Injury
Summary report: N
CONNECTION COMPONENT, ROTATIONAL VERSION, MEDIUM
MDR report key: 11008828
·
Received December 15, 2020
Report
- Report Number
- 3006721341-2020-00003
- Event Type
- Injury
- Date Received
- December 15, 2020
- Date of Event
- December 4, 2020
- Report Date
- December 8, 2020
- 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 2020-12-08, LINKBIO BECAME AWARE OF A FAILED CONNECTION COMPONENT THAT WAS ORIGINALLY IMPLANTED ON (B)(6) 2016 (PART # 16-2840/05, SN # (B)(4)). A NEW CONNECTION COMPONENT (PART # 16-2840/05, SN # (B)(4)) WAS IMPLANTED DURING THE REVISION SURGERY ON (B)(6) 2020.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1478624 | CONNECTION COMPONENT, ROTATIONAL VERSION, MEDIUM | ROTATING HINGED TOTAL KNEE PROSTHESIS | KRO | WALDEMAR LINK GMBH & CO. KG | 16-2840/05 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |