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 Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery: (b)(6) 2009 patient (r) side revision of competitor products (unknown implants revised).Revision surgery: (b)(6)2010 patient (l) side revision of competitor products (unknown implants revised).Revision surgery: (b)(6) 2022 patient (l) revision of depuy products: femoral component loose and needed revision.Implants insitu (affected items listed following under 8.3.2010 - refer to source data).Femoral components removed and revised to larger stem and sleeve.Existing plateau re used.Tibia remains insitu.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received indicated that there was no surgical delay reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.All available x-ray evidence were reviewed and cannot be establish the loosening condition reported.Based on the information, a defect or malfunction cannot be determined which could be attributed to the reported event, therefore the allegation is not confirmed.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: 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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• 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
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15112741
• Report Number: 1818910-2022-14210
• Device Sequence Number: 14850296
• Product Code: KRO
• UDI-Device Identifier: 10603295179481
• UDI-Public: 10603295179481
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K896048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 07/27/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 62-3411L
• Device Catalogue Number: 623411L
• Device Lot Number: 238411LA
• 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: 07/11/2022
• Supplement Date Received by Manufacturer: 08/10/2022; 10/06/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 08/16/2022; 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2008
• 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 KNEE FEM SLEEVE POR 34MM.; SROM NRH REPLC HINGE BRG QTY2.; SROM NRH TIB PLAT ASSY SM 21MM.; SROM NRH TIB SLEEVE POR 45MM.; SROM NRHFEM W/PIN SM LFT 66X62.; SROM* BASE TIB MOD UNTEXT MED.; SROM*DOME PAT UHMWPE 38MM.; SROM*EXTENSN,TIB STEM,11X100MM.; SROM*EXTNSN,FEM.STM,STR,15X100.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male