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 Problem Loss of or Failure to Bond (1068)

Patient Problem Pain (1994)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

(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 pain and loosening of the femoral component at an unknown interface.Depuy cement was used.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.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.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 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).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: 12108543
• MDR Text Key: 259660843
• Report Number: 1818910-2021-14264
• 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
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• 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: C61053
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LPS UNIV TIB HIN INS MED 14MM; SMARTSET GHV GENTAMICIN 40G; SROM NRHFEM W/PIN MED RT 71X66; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 115X18MM FLUTED; LPS UNIV TIB HIN INS MED 14MM; SMARTSET GHV GENTAMICIN 40G; SROM NRHFEM W/PIN MED RT 71X66; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 115X18MM FLUTED
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 125