MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA UNI FEMORAL SZ 5; KNEE PRIMARY : KNEE FEMORAL

Model Number 1024-08-500

Device Problem Naturally Worn (2988)

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

Event Date 08/04/2020

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

Patient had right unicompartmental knee replacement revised to right total knee replacement due to patella-femoral wear and pain.

Event Description

Additional information received states that the event was due to natural progression after 20 years insitu.The patella was native and no implant was removed during revision.There was also no allegation against the all poly tibia.

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: b5.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 no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.

• Type of Device: KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10420718
• MDR Text Key: 203335365
• Report Number: 1818910-2020-18287
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295001812
• UDI-Public: 10603295001812
• Combination Product (y/n): N
• PMA/PMN Number: K070849
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2009
• Device Model Number: 1024-08-500
• Device Catalogue Number: 967105
• Device Lot Number: 212416
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CMW 2 BONE CEMENT 20G.; CMW 2 BONE CEMENT 20G.; PFCSIG ALPLY UNITIB RM/LL8MMS4.; PFCSIG ALPLY UNITIB RM/LL8MMS4
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR