MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 23MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number 1987-27-123

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Joint Laxity (4526)

Event Date 11/26/2020

Event Type  Injury  

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 Description

Total knee replacement (revision) was needed because after falling (last year), patient´s knee started to be unstable in lateral and medial flexion and extension.Patient declared she did not feel her knee the same as before, surgeon explored her and decided to plan revision surgery.Tibial insert was indeed slightly mobilized, the spine was moving up and down and laterally.

Event Description

Affected side: right.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device could not confirm the reported event.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.H10 additional narrative:  added: d9 corrected: h3.

• Brand Name: LPS UNIV TIB HIN INS XSM 23MM
• 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: 11012488
• MDR Text Key: 221561985
• Report Number: 1818910-2020-26987
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295079446
• UDI-Public: 10603295079446
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1987-27-123
• Device Catalogue Number: 198727123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SROM*NRH REPL HINGE PIN/XSM/SM.
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR