MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS SM 12MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number	1987-27-212
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); No Code Available (3191)
Date of Event	10/13/2020
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
Change of lps small insert.Even though the insert seems not broken, there is a internal "shift between poly and" hinge part.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device was not able to confirm the reported event.The investigation found no evidence of product malfunction or product error and the need for corrective action was not established.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.Device history lot : a worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the provided lot code bfa0n0n is unrecognized in the unity master data, as400 and jde.
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: d10; corrected: h3.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: LPS UNIV TIB HIN INS SM 12MM
• Common Device Name: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10747593
• Report Number: 1818910-2020-23430
• Device Sequence Number: 19670211
• Product Code: KRO
• UDI-Device Identifier: 10603295079484
• UDI-Public: 10603295079484
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2020

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 Model Number: 1987-27-212
• Device Catalogue Number: 198727212
• Device Lot Number: BFAONON
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 11/16/2020; 12/15/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 11/19/2020; 12/23/2020
• 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: 29 YR