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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930); No Code Available (3191)
Date of Event	07/02/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient had a right tka utilizing an s-rom hinge implant.The patient had a poly swap due to infection on (b)(6) 2019.The patient fractured his femur at some point and the surgeon fears that the patient is still infected so he wanted to do a distal femur replacement.The femur was removed with the sleeve and stem intact.The surgeon resected more distal femur, cabled the femoral shaft, broached using the lps distal femur replacement and used stimulan beads.The surgeon was happy with the extension gap and patella tracking.Doi: (b)(6) 2018; doi: (b)(6) 2019 (insert); dor: (b)(6) 2020; right knee.
Additional 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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrected h6 patient code: no code available (3191) from the initial medwatch to capture patient harm device revision or replacement.

• Brand Name: SROM NRHFEM W/PIN MED RT 71X66
• Common Device Name: LPS AND S-ROM : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10275621
• Report Number: 1818910-2020-15886
• Device Sequence Number: 16718653
• Product Code: KRO
• UDI-Device Identifier: 10603295179474
• UDI-Public: 10603295179474
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K896048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 62-3401R
• Device Catalogue Number: 623401R
• Device Lot Number: 625035
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LPS UNIV TIB HIN INS MED 12MM; UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL STEM 75X16MM FLUTED
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 66 YR