MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SOL SYS 10.5 MMA 6IN; FEMORAL STEM

Catalog Number	157142000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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
Hcp is reporting to nca/ bfarm: "presentation in the emergency room on (b)(6) 2023 with pain in the right hip that had been present for 2 days.No trauma.X-ray in emergency room showed prosthetic socket fracture.Solution mma socket on the right was changed in 2016 from an s-rom prosthesis in 2016 - stem fracture after cementless hip tep on the right, pi 2008, change to revision stem 2016.Change to revision stem transfemoral on (b)(6) 2023: unilateral hip tep change with inlay change, transfemoral stem change to revitan revision stem 200x14 mm + 95 mm proximal, cable cerclage, ceramic head 28 mm, size s.
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.
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.
Additional Manufacturer Narrative
Product complaint #:(b)(4).Investigation summary : no device associated with this report was received for examination.Dhr review: product description: sol sys 10.5 mma 6in.Product code: 157142000.Lot number: c38709.1) quantity manufactured: (b)(4).2) date of manufacture: 5/31/2016.3) any anomalies or deviations identified in dhr: no.4) expiry date: 4/30/2026.5) ifu reference: (b)(4).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 : dhr review: product description: sol sys 10.5 mma 6in.Product code: 157142000.Lot number: c38709.1) quantity manufactured: (b)(4).2) date of manufacture: 5/31/2016.3) any anomalies or deviations identified in dhr: no.4) expiry date: 4/30/2026.5) ifu reference: (b)(4).

• Brand Name: SOL SYS 10.5 MMA 6IN
• Common Device Name: FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18464829
• Report Number: 1818910-2024-00549
• Device Sequence Number: 20619227
• Product Code: LPH
• UDI-Device Identifier: 10603295060963
• UDI-Public: 10603295060963
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K953703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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
• Report Date (Section B): 01/08/2024

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: 04/30/2026
• Device Catalogue Number: 157142000
• Device Lot Number: C38709
• 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: 12/21/2023
• Supplement Date Received by Manufacturer: 01/18/2024; 01/31/2024; 02/08/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 01/26/2024; 02/07/2024; 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• 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: DELTA CER HEAD 12/14 28MM +1.5.; DUR MAR 10D LINER 28IDX48OD.; SOL SYS 10.5 MMA 6IN.; UNK HIP FEMORAL SLEEVE SROM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female