MAUDE Adverse Event Report: DEPUY RAYNHAM 1219655 PFC SIG RPF INS SZ 2 10MM; KNEE TIBIAL BEARING/INSERT

Catalog Number	951020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/27/2017
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
It was reported that during explantation surgeon noted catastrophic failure of polyethylene insert.On (b)(6) 2017 upon evaluation of the explant photographs, implant fracture is identified.
Additional Manufacturer Narrative
No device associated with this report was received for examination, however review of the provided explant photographs confirms the reported event.A dhr review was conducted on the provided vendor lot code and no deviations or anomalies were noted.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: PFC SIG RPF INS SZ 2 10MM
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY RAYNHAM 1219655; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6875406
• Report Number: 1818910-2017-24897
• Device Sequence Number: 1444217
• Product Code: NJL
• UDI-Device Identifier: 10603295230298
• UDI-Public: 10603295230298
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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: 951020
• Device Lot Number: BFA01J7000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 09/22/2017
• 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: 70 YR
• Patient Weight: 62