MAUDE Adverse Event Report: DEPUY IRELAND 9616671 SIGMA STAB XLK INS 2.5 12.5MM; KNEE TIBIAL BEARING/INSERT

Catalog Number	158122112
Medical Device Problem Code	Insufficient Device Problem Information (3190)
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
Der stated that the patient had a left trk in 2014 (a sigma ps fb).Patient knee was tapped due to pain.Patient brought to or friday (b)(6).Left knee opened and poly removed.I&d performed.New poly implanted, left knee closed.
Additional Manufacturer 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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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: SIGMA STAB XLK INS 2.5 12.5MM
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 6732066
• Report Number: 1818910-2017-21535
• Device Sequence Number: 652506
• Product Code: JWH
• UDI-Device Identifier: 10603295064183
• UDI-Public: 10603295064183
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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: 158122112
• Device Lot Number: 7852284
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 08/21/2017
• 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: 73 YR
• Patient Weight: 88