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

Catalog Number 950501024

Device Problems Device Issue (2379); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189); No Code Available (3191)

Event Date 03/02/2018

Event Type  Injury  

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 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.

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
• Type of Device: PATELLA TRIALS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7373205
• MDR Text Key: 103547998
• Report Number: 1818910-2018-56144
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295224266
• UDI-Public: 10603295224266
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 950501024
• Device Lot Number: AF0607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2018
• Date Device Manufactured: 06/15/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR