MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SOL 13.5 BOW RT 8.0 12/14; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Model Number	1571-84-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Occupation: lawyer.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.
Event or Problem Description
Legal letter received: our client was admitted on the (b)(6) 2018 for elective right hip revision surgery.We attach implant traceability stickers for your attention.In the next year of this surgery our client informs us that he suffered excruciating pain as a result this surgery and learn in or around early (b)(6) 2019 that the prothesis that was implanted on (b)(6) 2018 was in fact broken.This resulted in our client having to have a right proximal fibular replacement due to the broken prothesis on the (b)(6) 2019.As previously stated above patient had to have a further operation on the (b)(6) 2019 as a result of the broken prothesis.The operation that took place in 2019 involved a dissection down to the bone; the broken stem of implant identified; cables of hook plate cut and plate removed.
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 was performed, for the finished device lot number: 501849, product code:157184000.And no non-conformances/ manufacturing irregularities were identified.

• Brand Name: SOL 13.5 BOW RT 8.0 12/14
• Common Device Name: SOLUTION STEM IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15699307
• Report Number: 1818910-2022-21626
• Device Sequence Number: 6227265
• Product Code: LPH
• UDI-Device Identifier: 10603295061250
• UDI-Public: 10603295061250
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K953703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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 Expiration Date: 02/29/2024
• Device Model Number: 1571-84-000
• Device Catalogue Number: 157184000
• Device Lot Number: 501849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2014
• 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: DELTA CER HEAD 12/14 32MM +1; SOL 13.5 BOW RT 8.0 12/14; UNK - CABLE/WIRE; UNK - CONSTRUCTS: PLATE/SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male