MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SOL SYS 8/18.0 LRG ST; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Model Number	1572-02-180
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medical records received.After review of medical records, visit notes on (b)(6) 2018 indicated that patient had complaints of occasional stiffness and soreness.Visit notes on (b)(6) 2019 reported that patient had a lower lumbar pain bilateral lower extremity pain into the posterior thigh, quad and posterior calves.Urologist consultation reported that patient prostate was enlarge.Doi:(b)(6) 2009 (cup).Doi: (b)(6) 2017; dor: none reported; left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this report was not returned for analysis.All available x-rays were reviewed, it is observed that stem has fractured at the body.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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.

• Brand Name: SOL SYS 8/18.0 LRG ST
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16213749
• Report Number: 1818910-2023-01568
• Device Sequence Number: 19926061
• Product Code: LPH
• UDI-Device Identifier: 10603295061465
• UDI-Public: 10603295061465
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K030979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: 1572-02-180
• Device Catalogue Number: 157202180
• Device Lot Number: 731121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2016
• 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
• Patient Age: 64 YR
• Patient Sex: Male