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

Model Number 62-3401L

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Discomfort (2330); No Code Available (3191)

Event Date 07/20/2020

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

The patient was revised to addressed loosening of the femoral component at cement to implant interface.It was also reported that the patient is having pain and discomfort in the knee surgeon notice that the femur may have been loose.So he removed hinge with sleeve, stem and poly and replaced with a new hinge, cemented stem and poly.I don¿t know when or where it was previously implanted and couldn¿t locate some of the lot numbers on the implants.Doi: (b)(6) 2013.Dor: (b)(6) 2020.Left 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.

• Brand Name: SROM NRHFEM W/PIN MEDLFT 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: 10356980
• MDR Text Key: 201386575
• Report Number: 1818910-2020-17366
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295179467
• UDI-Public: 10603295179467
• 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: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 62-3401L
• Device Catalogue Number: 623401L
• Device Lot Number: 346433
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LPS UNIV TIB HIN INS MED 18MM; SROM NRHFEM W/PIN MEDLFT 71X66; UNIVERSAL FEM SLV DIS POR 34MM; UNIVERSAL STEM 75X18MM FLUTED; LPS UNIV TIB HIN INS MED 18MM; SROM NRHFEM W/PIN MEDLFT 71X66; UNIVERSAL FEM SLV DIS POR 34MM; UNIVERSAL STEM 75X18MM FLUTED
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR