MAUDE Adverse Event Report: DEPUY RAYNHAM ¿ 1219655 TC3 RP TIBIAL INSERT S4,17.5; KNEE TIBIAL BEARING/INSERT

Catalog Number 962354

Device Problem Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671)

Event Date 04/29/2017

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

Patient was revised to address aseptic femoral loosening at the cement-implant interface secondary to a broken adapter and adapter bolt.Cement manufacturer is unknown.Update (b)(6) 2017: additional information received.Clinical der indicates that the patient was revised to address a loose femoral adapter bolt.This event meets the definition of serious and is considered moderate.It is definitely related to device and definitely not related to procedure.Update (b)(6) 2017: additional information received.Review of provided patient x-rays confirmed the adapter bolt has fractured.There is no evidence to confirm the reported breakage of the adapter.Update (b)(6) 2017: pre-op assessment (b)(6) 2017: patient states he recently felt a pop in his knee while getting out of a chair, since that time, he has had a hard time walking or bending his knee.He has had to keep his knee in extension most of the time.X-rays obtained in office reveal a revision right total knee replacement with a bolt that has come loose in the femoral component as well as gross loosening of the femoral component with periprosthetic osteolysis.Op- notes (b)(6) 2017: femoral component was grossly loose.There was a significant amount of metallosis type synovium.A fair amount of extensive debridement was necessary due to the metallosis.The metaphyseal sleeve was extremely well ingrown on the femur.There was a small area under the thick tibial tray anteromedially that osteolysed on the tibial side.The broken bolt as well as the femoral valgus adapter were all removed from the patient successfully.Removal of the adapter from the fixed metaphyseal sleeve did not cause any micromotion of the sleeve as it was extremely well ingrown.

Manufacturer Narrative

The device associated with this reported event was not returned for examination.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TC3 RP TIBIAL INSERT S4,17.5
• Type of Device: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY RAYNHAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY RAYNHAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6731196
• MDR Text Key: 80625134
• Report Number: 1818910-2017-21431
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295242390
• UDI-Public: 10603295242390
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 962354
• Device Lot Number: C4RHG4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2008
• 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
• Patient Age: 56 YR
• Patient Weight: 100