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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Delivery of all the instrumentation and implants, except the noiles femur implants.No possibility to troubleshoot around the clinic because the only depot is in other city (b)(6).Surgery initiated at 2pm and completed at 6pm.The surgeon made the decision to perform the surgery, performed the bone cuts and tests, then put a spacer in place for re-operation on (b)(6) 2022 with the removal of the spacer and the installation of the final implants.The implants were checked only at the time of the intervention by the j&j technical advisor, who warned the surgeon as soon as she had discovered it.The implant kits could not have been shown as missing on the delivery form as it was not reserved.Several elements involved, including the lack of staff of the team ready to sustain quality work.
Additional 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 a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• 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
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14218063
• Report Number: 1818910-2022-07627
• Device Sequence Number: 5359271
• Product Code: KRO
• UDI-Device Identifier: 10603295179474
• UDI-Public: 10603295179474
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K896048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 05/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SROM NRH FEM W/PIN XSMRT 66X58; SROM NRHFEM W/PIN MED RT 71X66; SROM NRHFEM W/PIN SM RT 66X62
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown