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

Catalog Number 157202106

Device Problems Fracture (1260); Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Cardiac Arrest (1762); Infarction, Cerebral (1771); Unspecified Infection (1930); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)

Event Type  Injury  

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 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).

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
• Type of Device: SOLUTION STEM IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 8514051
• MDR Text Key: 141925832
• Report Number: 1818910-2019-90649
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295061410
• UDI-Public: 10603295061410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 157202106
• Device Lot Number: DF4FH1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 12/04/2019
• Supplement Dates FDA Received: 12/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention