MAUDE Adverse Event Report: DEPUY RAYNHAM 1219655 TC3 RP TIBIAL INSERT S5,10.0; KNEE TIBIAL BEARING/INSERT

Catalog Number	962361
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient was revised to address instability, dislocation, pain and broken spine on ps insert.
Additional Manufacturer Narrative
Additional narrative: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Review of the device history records did not reveal any related manufacturing deviations or anomalies on the reported lot number.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TC3 RP TIBIAL INSERT S5,10.0
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY RAYNHAM 1219655; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6731466
• Report Number: 1818910-2017-21490
• Device Sequence Number: 16349270
• Product Code: NJL
• UDI-Device Identifier: 10603295242482
• UDI-Public: 10603295242482
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 962361
• Device Lot Number: 212230
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 181