MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SOL SYS 8/10.5 LRG ST; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Catalog Number	157202106
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Infarction, Cerebral (1771); Unspecified Infection (1930); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)
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.Occupation is a non-healthcare professional.(b)(4).
Event or Problem Description
Litigation alleges stroke, heart attack, component fracture, dislocation, infection, loosening of stem and elevated metal ions.Doi: (b)(6) 2011, (head, liner & stem) ; doi: (b)(6) 2009, (cup, screw); dor: (b)(6) 2012, (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 will be filed as appropriate.

• Brand Name: SOL SYS 8/10.5 LRG ST
• Common Device Name: SOLUTION STEM IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 8514051
• Report Number: 1818910-2019-90649
• Device Sequence Number: 19314807
• Product Code: LPH
• UDI-Device Identifier: 10603295061410
• UDI-Public: 10603295061410
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K060581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 157202106
• Device Lot Number: DF4FH1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 12/31/2019
• 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