MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 14MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number 1987-27-114

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/07/2021

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

The patient was revised to address suspected infection.Patient also has a dislocated patella so surgeon chose to exchange modular components and also chose to shorten the femoral side.A thorough i&d and a lateral release were performed.Surgeon also placed antibiotic beads.No loosening and delay to surgery reported.Doi: (b)(6) 2018, dor: (b)(6) 2021, left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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.

• Brand Name: LPS UNIV TIB HIN INS XSM 14MM
• 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: 11200951
• MDR Text Key: 227748352
• Report Number: 1818910-2021-01499
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295079408
• UDI-Public: 10603295079408
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1987-27-114
• Device Catalogue Number: 198727114
• Device Lot Number: HU9746
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LPS DISTAL FEM COMP XSM LT; LPS FEM TO SLEEVE ADAPTER +10; LPS UNIV TIB HIN INS XSM 14MM; LPS XX-SM HINGE PIN; LPS DISTAL FEM COMP XSM LT; LPS FEM TO SLEEVE ADAPTER +10; LPS UNIV TIB HIN INS XSM 14MM; LPS XX-SM HINGE PIN
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR