MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 3 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number 101214030

Device Problems Loss of Osseointegration (2408); Biocompatibility (2886)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)

Event Date 05/29/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Initial reporter occupation: attorney.

Event Description

Litigation alleges that the patient suffers from pain and tenderness in hip and groin, along with several dislocations.Update 06 jul 2018 receipt of ppf and sticker sheets.In addition to what previously alleged, ppf alleges loosening of cup and stem, elevated metal ions.

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.

• Brand Name: TRI-LOCK BPS SZ 3 HI OFFSET
• Type of Device: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8202370
• MDR Text Key: 131591209
• Report Number: 1818910-2018-79332
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295001058
• UDI-Public: 10603295001058
• Combination Product (y/n): N
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 101214030
• Device Lot Number: C6DD3A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 82