MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SOL SYS 8/10.5 SML ST; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Model Number	1572-01-106
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Osteolysis (2377); Test Result (2695); No Code Available (3191)
Date of Event	08/20/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Initial reporter occupation: non-healthcare professional "attorney".(b)(4).
Event or Problem Description
The patient was then revised a second time on (b)(6) 2014 for pain, osteolysis, metallosis, malpositioned/loose cup, and 2 broken screws and 2 loose screws.Litigation also alleges elevated metal ion levels.Update in addition in what was previously alleged.Ppf alleges constrained liner, loosening of cup, dislocation and elevated metal ions.Cup, liner, and screws were non-depuy products.Doi: (b)(6) 2013; dor: (b)(6) 2014, (right hip).
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.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 SYS 8/10.5 SML ST
• Common Device Name: SOLUTION STEM IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 8464018
• Report Number: 1818910-2019-88960
• Device Sequence Number: 1341661
• Product Code: LPH
• UDI-Device Identifier: 10603295061328
• UDI-Public: 10603295061328
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K060581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2014

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: 1572-01-106
• Device Catalogue Number: 157201106
• Device Lot Number: E4XAN1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 02/06/2020
• 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: 61 YR