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 Codes	Fracture (1260); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
Revision hip replacement.Previously revised using a solution stem at smsa several years earlier.Solution stem had recently broken mid shaft.Review of the x-rays with the surgeon concluded that the solution stem had been undersized due to a large amount of cement not removed from the femoral shaft from the primary surgery.The end point of the large piece of cement may have not only caused the solution to be undersized, but also acted as a stress riser on the stem.The stem broke just above this cement.
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.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

• 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
• MDR Report Key: 10221170
• Report Number: 1818910-2020-14860
• Device Sequence Number: 19493372
• Product Code: LPH
• UDI-Device Identifier: 10603295061250
• UDI-Public: 10603295061250
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K953703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2020

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 Model Number: 1571-84-000
• Device Catalogue Number: 157184000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/07/2020; 07/22/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/09/2020; 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SOL 13.5 BOW RT 8.0 12/14
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR