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

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Inflammation (1932); Pain (1994); No Code Available (3191)

Event Date 10/13/2020

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

Change of lps small insert.Even though the insert seems not broken, there is a internal "shift between poly and" hinge part.

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.

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
• Type of Device: 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
• MDR Text Key: 213425956
• Report Number: 1818910-2020-23430
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295079484
• UDI-Public: 10603295079484
• Combination Product (y/n): N
• PMA/PMN Number: K091453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 11/16/2020; 12/15/2020
• Supplement Dates FDA Received: 11/19/2020; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR