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

Catalog Number	157184000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	10/10/2019
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
Date: (b)(6) 2019.Revision right total hip for peri prosthetic fracture.Broken solution stem- spontaneous- please investigate reason for same.Surgeon requested investigation.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > the returned product confirmed that the stem had fractured.Investigation concluded that the mode of failure of the prosthesis is multi-factorial and consideration has to be given to all other potential influences such as, surgical process, patient variables e.G.Activity, weight, bmi and use, anatomical considerations and patient changes over time.This report details the findings from a review of the explants and information as supplied at the time of evaluation.Any conclusions from this data have to be placed into context with all other relevant factors.It is unlikely that a potential product issue was present.No corrective action is required.Complaints will continue to be monitored post market surveillance per (b)(4).The returned product shall be retained for future reference if information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 9279109
• Report Number: 1818910-2019-114110
• Device Sequence Number: 2733862
• Product Code: LPH
• UDI-Device Identifier: 10603295061250
• UDI-Public: 10603295061250
• Combination Product (Y/N): N
• PMA/510(K) Number: K953703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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: 02/28/2024
• Device Catalogue Number: 157184000
• Device Lot Number: 501849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR