MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN KNEE TIBIAL INSERT

Catalog Number UNK KNEE TIBIAL INSERT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Synovitis (2094); Tissue Damage (2104); Osteolysis (2377); Not Applicable (3189)

Event Date 08/21/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Reviewed medical records received on (b)(6) 2018.Right knee revised to address pain and aseptic loosening of the tibia base plate.Revising surgeon identified marked synovitis with metallosis.He also stated that the femur was well-fixed, but the tibia base plate was grossly loose.He also indicated that the tibia prosthesis had subsided posteromedially, and there was osteolysis present beneath both tibia and femur components.Femur, tibia and insert components were all revised to competitor knee products; patella was retained.Pathology specimens sent intra-op confirmed metallosis in the synovium.No product or lot code information provided in records for primary attune total knee, nor the manufacturer of the bone cement used.Doi: (b)(6) 2014; dor: (b)(6) 2017; (right knee).

Manufacturer Narrative

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

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthese considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative:  added: h6 (device).

• Brand Name: UNKNOWN KNEE TIBIAL INSERT
• Type of Device: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7587308
• MDR Text Key: 110627824
• Report Number: 1818910-2018-61774
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL INSERT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR