MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA DIS AUG 8MM,SZ3,LEFT; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Catalog Number	960862
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient was revised due to loosening of the femur at the bolt interface.Doi: (b)(6) 2017 dor: (b)(6) 2024 affected side: left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.
Event or Problem Description
Additional information received: a.Was there a surgical delay? if yes, what is the duration of the delay? -no.B.Please clarify the loosening component/s.- femur and bolt.C.Please provide the loosening interface.-femur/bolt.D.Please confirm if the cement was manufactured by depuy? if yes, please provide the part and lot numbers and quantity of the cement.-no information for which cement was used.E.Was there any suggestion by anyone indicating that there was or may be deficiency with the sigma fem adapter 5 degree and sig fem adap +2/-2 offset bolt.If yes, please provide details.-surgeon just said he thought it broke.F.Please confirm if the bolt disassociated from the adapter.-bolt did not disassociate from adapter.
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.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE RAYNHAM MFG SITE; 325 paramount drive; raynham MA
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18912269
• Report Number: 1818910-2024-05819
• Device Sequence Number: 12452603
• Product Code: JWH
• UDI-Device Identifier: 10603295234289
• UDI-Public: 10603295234289
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2024

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 Expiration Date: 05/31/2024
• Device Catalogue Number: 960862
• Device Lot Number: 532501
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 03/13/2024; 04/12/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 03/22/2024; 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2014
• 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: MBT REVISION CEM TIB TRAY SZ 3; MBT TRAY SLEEVE POR M/L 37MM; PFC SIGMA FEM POST AUG SZ3 4MM; PFC SIGMA FEM POST AUG SZ3 8MM; PFC*SIGMA DIS AUG 8MM,SZ3,LEFT; PFC*SIGMA TC3 FEM LEFT SZ3; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S3,12.5; UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X16MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 90 KG