MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL ADAPTOR

Catalog Number UNK KNEE FEMORAL ADAPTOR

Device Problem Fracture (1260)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 09/09/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Clinical notification received for revision due to instability.Date of implant: (b)(6) 2007; date of revision: (b)(6) 2022; (right knee).Treatment: revision; femoral and tibial components were removed.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: the device associated with this complaint was not returned.Photo evidence and x-rays provided were reviewed and found no implant issue.The reported condition was not confirmed.Depuy considers, the investigation closed.Should additional information be received, the information will be reviewed.And the investigation will be re-opened as necessary.Device history lot: a manufacturing records evaluation (mre) was not performed, as no lot number was provided for this device.

• Brand Name: UNKNOWN KNEE FEMORAL ADAPTOR
• Type of Device: KNEE FEMORAL ADAPTOR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15586446
• MDR Text Key: 301552580
• Report Number: 1818910-2022-20142
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

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 Catalogue Number: UNK KNEE FEMORAL ADAPTOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MBT CEM KEEL TIB TRAY SZ3; PFC SIGMARP CV TB/IN S3 12.5; PFC SIGMARP CV TB/IN S3 12.5; PFC SIGMARP CV TB/IN S3 12.5; PFC*SIGMA C/R NPOR FEM RT SZ 3; PFC*SIGMA C/R NPOR FEM RT SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,38; PFC*SIGMA/OV/DOME PAT 3PEG,38; UNK KNEE FEMORAL ADAPTOR LPS
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White