MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE M/B PAT CEM STD+; KNEE PATELLA COMPONENT

Catalog Number	129409750
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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 patient fell and complained of pain.Surgery revealed that the patella poly had popped off metal backing.A poly patella replacement was implanted but did not seem to rotate very well so the surgeon requested that another poly from a metal backed patella be implanted.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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: LCS COMPLETE M/B PAT CEM STD+
• Common Device Name: KNEE PATELLA COMPONENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7072598
• Report Number: 1818910-2017-50493
• Device Sequence Number: 1186424
• Product Code: NJL
• UDI-Device Identifier: 10603295022725
• UDI-Public: 10603295022725
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2017

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: 129409750
• Device Lot Number: 8038505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 01/17/2018; 09/06/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 01/22/2018; 09/11/2018
• 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: 54 YR