MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 8 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number	101204080
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fatigue (1849); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Weakness (2145); Depression (2361); Confusion/ Disorientation (2553); Test Result (2695); Fibrosis (3167); Not Applicable (3189); No Code Available (3191)
Date of Event	08/25/2017
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
Pfs and medical records received.Pfs alleges continuous and persistent pain, fatigue, sleep disturbance, affecting thought process, depression and impaired activities of daily living.After review of medical records for mdr reportability, it was stated that the patient was revised to address pain due to implant failure.Revision notes stated that there was a turbid fluid consistent with metallosis, tremendous amount of scar tissue and arthrofibrosis.Clinic visit stated that mri of the hip and pelvis demonstrate some relatively small fluid collection around the greater trochanter and there is trace hip effusion.Cobalt ion level is above 7 ppb.Doi: (b)(6) 2010; dor: (b)(6) 2017; right hip.
Additional 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.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .
Additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRI-LOCK BPS SZ 8 STD OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7376870
• Report Number: 1818910-2018-56238
• Device Sequence Number: 13796408
• Product Code: KWA
• UDI-Device Identifier: 10603295000792
• UDI-Public: 10603295000792
• 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: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2018

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: 03/09/2020
• Device Catalogue Number: 101204080
• Device Lot Number: EH9GG1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 04/09/2018; 08/20/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 04/11/2018; 08/27/2018
• 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: 73 YR
• Patient Weight: 93