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	Difficult to Insert (1316); Off-Label Use (1494)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while putting final insert implant we have faced challenge with locking x-small hinge insert with small s-rom noils femur.So, we have revised the femur intraoperatively although cementing has been done.There was a 60 minute surgical delay.Doe: (b)(6) 2023.
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.A.Was there an allegation against the x-small hinge insert? or the s-rom noils femur? if the x-small hinge insert, please provide the lot and product number.There were no issues with the x-small insert only the s-rom noils femur was mismatched b.Please clarify if this is a primary surgery or a revision surgery.If a revision: it was a revision surgery.B1.Please provide the primary surgery date.Primary was performed 10 years before somewhere else.B2.Reason for revision implant was loosed (that¿s why the revision was required).
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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 medical device problem code removed pe code: implant-implant fit mating parts do not fit together intraoperatively.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the photo investigation revealed that srom nrhfem w/pin sm lft 66x62 had no defect shown in the evidence provided.Per s-rom noiles surgical technique (dsus/jrc/0414/0052) inserts compatible with s-rom and lps femurs must match femur size-to-size.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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).A records evaluation (mre) was not performed.H10 additional narrative: added: b5.
Event or Problem Description
Additional information received indicates that no depuy products were involved in the revision surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the device found nothing indicative of a device nonconformance, however some extraction damage can be seen.Per s-rom noiles surgical technique (dsus/jrc/0414/0052) inserts compatible with with s-rom and lps femurs must match femur size-to-size.The reported allegation can be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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).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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16528904
• Report Number: 1818910-2023-05652
• Device Sequence Number: 5246272
• Product Code: KRO
• UDI-Device Identifier: 10603295179481
• UDI-Public: 10603295179481
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K896048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,Followup,Followup
• Report Date (Section B): 03/13/2023

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
• Device Model Number: 62-3411L
• Device Catalogue Number: 623411L
• Device Lot Number: JT9536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 03/14/2023; 04/13/2023; 04/19/2023; 05/08/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 04/03/2023; 04/13/2023; 04/21/2023; 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2022
• 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 NRHFEM W/PIN SM LFT 66X62; UNK KNEE TIBIAL INSERT SROM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male