MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM NRHFEM W/PIN SM LFT 66X62; LPS AND S-ROM : KNEE FEMORAL

Model Number	62-3411L
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Code Available (3191); Insufficient Information (4580)
Date of Event	10/21/2020
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
Patient was revised due to loosening of the srom femur at the bone to implant interface.Post of srom hinge femoral component broke in-situ and part of post was stuck in universal femoral sleeve.Surgeon believes it broke under pressure.Surgeon had to remove femoral sleeve and press fit stem.Femur was revised.Doi: (b)(6) 2017.Dor: (b)(6) 2020; left knee.
Additional 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 : dhr reviewed no deviations or nonconformance's were noted.H6 clinical code: removed the code for inadequate osteointegration and replaced with insufficient information (e2401).H6 medical device problem code: removed code for osseointegration and replaced with loss of or failure to bond (a040102).

• Brand Name: SROM NRHFEM W/PIN SM LFT 66X62
• 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: 10792900
• Report Number: 1818910-2020-24032
• Device Sequence Number: 2988431
• Product Code: KRO
• UDI-Device Identifier: 10603295179481
• UDI-Public: 10603295179481
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K896048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 62-3411L
• Device Catalogue Number: 623411L
• Device Lot Number: C88168
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LPS UNIV TIB HIN INS SM 12MM; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 150X20MM FLUTED; LPS UNIV TIB HIN INS SM 12MM; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 150X20MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR