MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 2 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number	101214020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Tissue Damage (2104); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)
Date of Event	11/16/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Litigation alleges that the patient suffers from pain, discomfort, limited mobility, and a constant limp.Update: 11/20/2012 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records indicate that the patient was revised because of pain, metallosis, elevated ion levels, dislocation issues, and vertical cup.Records are available for further review.Dor: (b)(6) 2013.Update ad 13 apr 2018: pinnacle ppf and medical records received.In addition to what was previously alleged.Ppf alleges dislocation with open reduction and metal wear/ metallosis confirmed in medical records.After review of medical records for mdr reportability, the patient was revised to address painful left total hip replacement secondary to elevated metal ions, dislocation, vertical placement of cup, and inflammation.Operative notes reported there was a moderate amount of dark tinged fluid consistent with metallosis, a fair amount of metallosis debris around the cup and tissues.Doi: (b)(6) 2009; dor: (b)(6) 2013; left hip.

• Brand Name: TRI-LOCK BPS SZ 2 HI OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7508643
• Report Number: 1818910-2018-59434
• Device Sequence Number: 16201433
• Product Code: KWA
• UDI-Device Identifier: 10603295001041
• UDI-Public: 10603295001041
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

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 Expiration Date: 07/14/2019
• Device Catalogue Number: 101214020
• Device Lot Number: D1WED1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/11/2018
• 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: 46 YR
• Patient Weight: 51