MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM NRHFEM W/PIN MED RT 71X66; LPS AND S-ROM : KNEE FEMORAL

Model Number 62-3401R

Device Problems Loss of or Failure to Bond (1068); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Date 04/12/2021

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

The patient was revised to address a dislocated total knee and loosening of the femoral component at the cement to implant interface.Competitor cement was used.The surgeon elected to revise the knee by switching the poly.Doi: (b)(6) 2021, dor: (b)(6) 2021, right 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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: SROM NRHFEM W/PIN MED RT 71X66
• Type of Device: LPS AND S-ROM : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11737063
• MDR Text Key: 247687299
• Report Number: 1818910-2021-08980
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295179474
• UDI-Public: 10603295179474
• Combination Product (y/n): N
• PMA/PMN Number: K896048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 62-3401R
• Device Catalogue Number: 623401R
• Device Lot Number: J95C84
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR BONE CEMENT; LPS UNIV TIB HIN INS MED 23MM; SROM NRHFEM W/PIN MED RT 71X66; COMPETITOR BONE CEMENT; LPS UNIV TIB HIN INS MED 23MM; SROM NRHFEM W/PIN MED RT 71X66
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR