MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SOL 13.5 BOW LT 10.0 12/14; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Model Number	1571-24-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Metal Related Pathology (4530)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter 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
Patient is a case of revision total hip replacement on (b)(6) 2010.The primary surgery was done in (b)(6) 2019 with s-rom stem, pinnacle cup, metal head, proximal sleeve, acetabular liner and revised with solution stem and metal head.His cobalt chrome and chromium levels are going up (on (b)(6) 2017 - chromium 5.80 and cobalt chrome 1.82 and on 22°.2.2019 - chromium 22.05, cobalt chrome <2.50).Mars mri result awaited.He has restricted movement which compromises his daily activities.He has been advised revision total hip replacement as early as possible.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SOL 13.5 BOW LT 10.0 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15249950
• Report Number: 1818910-2022-16102
• Device Sequence Number: 20444877
• Product Code: LPH
• UDI-Device Identifier: 10603295060826
• UDI-Public: 10603295060826
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K953703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 08/18/2022

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 Model Number: 1571-24-000
• Device Catalogue Number: 157124000
• Device Lot Number: D1KG31000
• 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: 08/08/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2009
• 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: ARTICUL/EZE BALL 28 +8.5 BL; PINNACLE BANTAM ACET CUP 44MM; PINNACLE MTL INS NEUT28IDX44OD; SOL 13.5 BOW LT 10.0 12/14
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male