MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS M BRDG BRG STD+/LG 10.0; LCS : KNEE TIBIAL INSERT

Model Number	1278-24-025
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
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
The patient is planned for a revision of lcs brg bearing inserts due wear after 25 years in-situ.Product will be not returned.Occurred post-implant.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: 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.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.
Event or Problem Description
The menicsal bearing is worn out causing instability in the patient knee.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added: b5, e1 (facility name).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: LCS M BRDG BRG STD+/LG 10.0
• Common Device Name: LCS : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10197389
• Report Number: 1818910-2020-14447
• Device Sequence Number: 10984705
• Product Code: NJL
• UDI-Device Identifier: 10603295020400
• UDI-Public: 10603295020400
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1278-24-025
• Device Catalogue Number: 127824025
• Device Lot Number: SJ4CA1021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/09/2020; 07/17/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 07/03/2020; 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1