FDA Adverse Event
Injury
Summary report: N
NATURAL-KNEE II SYSTEM POSTERIOR STABILIZED TIBIAL INSERT
MDR report key: 1020357
·
Received March 27, 2008
Report
- Report Number
- 1822565-2008-00131
- Event Type
- Injury
- Date Received
- March 27, 2008
- Date of Event
- December 5, 2007
- Report Date
- March 14, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- HSH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: CAUSE CANNOT BE DEFINITIVELY DETERMINED. NO PRODUCT OR X-RAYS WERE RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.
Description of Event or Problem · 1
IT IS REPORTED THAT IN LATE 2007, BREAKAGE OCCURRED ON THE LOCKING PART ON THE BACKSIDE OF THE INSERT. EXACT IMPLANT AND EXPLANT DATES ARE UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NATURAL-KNEE II SYSTEM POSTERIOR STABILIZED TIBIAL INSERT | KNEE PROSTHESIS | HSH | ZIMMER, INC. | NA | 1630653 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |