MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SP2 MI PATELLA WAFER; PATELLA TRIALS

Catalog Number	950501024
Medical Device Problem Codes	Device Issue (2379); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189); No Code Available (3191)
Date of Event	03/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 states that the sp2 mi patella wafer had disassociated after being applied to prepared patella surface at some point during the procedure (patella was prepared first).The wafer migrated to superior lateral capsule and was retained in the wound after closure.The retained instrument was identified by a film taken in (b)(6) and the instrument was subsequently retrieved during a separate procedure three hours post op of the tka.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SP2 MI PATELLA WAFER
• Common Device Name: PATELLA TRIALS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 7373205
• Report Number: 1818910-2018-56144
• Device Sequence Number: 16430828
• Product Code: LXH
• UDI-Device Identifier: 10603295224266
• UDI-Public: 10603295224266
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/02/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 950501024
• Device Lot Number: AF0607
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/02/2018; 05/01/2018; 11/08/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 03/27/2018; 05/01/2018; 11/08/2018
• 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: 65 YR