MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 2 HI OFFSET; HIP FEMORAL STEM

Catalog Number	101214020
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104)
Date of Event	05/08/2017
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.
Event or Problem Description
New unity record created in order to update legacy complaint number (b)(4).Litigation alleges that patient suffers from constant hip pain, back pain and discomfort.It is sometimes not possible for patient to perform her routine daily activities due to the pain.The incision site around the hip implant sometimes still opens up and bleeds years after her original implant surgery.Additionally, it is alleged that patient has elevated metal ion levels.Patient's preliminary disclosure form was received on 6/29/2012, which provided part/lot information.Doi: (b)(6) 2008 - dor: none reported (left hip).**patient is a resident of (b)(6).Update nov 15 and 28, 2017: medical records received.After review of medical records for the mdr reportability, in addition to what was previously reported, the patient was revised to address metallosis and trunnionosis.Revision notes reported a metallosis-type fluid, significant trunnionosis with grey metal black particles in the femoral head, and no real incorporation of bone into the acetabular shell.Laboratory result for cobalt is above 7ppb.Clinical notes reported inability to bear weight, history of wound dehiscence, soft tissue atrophy, limited rom, decreased motor strength, flexed forward ambulation with cane and significant limp.X-ray shows the femoral stem is somewhat proud and slightly varus.Added asr taper sleeve and tri-lock stem.Doi: sep 23, 2008 dor: may 8, 2017 (left hip).
Additional Manufacturer Narrative
(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.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 2 HI OFFSET
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7114900
• Report Number: 1818910-2017-51592
• Device Sequence Number: 1933475
• Product Code: KWA
• UDI-Device Identifier: 10603295001041
• UDI-Public: 10603295001041
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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: 101214020
• Device Lot Number: CN6DB1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 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: 70 YR