MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 4 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number	1012-14-040
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Injury (2348); No Code Available (3191)
Date of Event	09/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint: (b)(4).Initial reporter occupation: lawyer.(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 papers allege pain, difficulty engaging in activities of daily living, further deteriorating of the hip joint, damage to surrounding tissues, will be required to undergo an explantation surgery which will involve significant financial expenses, pain and suffering and physical disfigurement.Doi: (b)(6) 2009 - dor: none reported (right hip).Update: 8 dec 2017: claim letter received.Claim letter alleges injury to the patient.Added complainant information.Doi: (b)(6) 2009-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.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.Per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device(s) was identified.Monitor ¿ exempt per wi-7915 - known possible complication of joint replacement surgery.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found two additional reports (wpc 4488-2008, com-123258) against the provided tri-lock sz 4 hi offset product code 101214040, lot number ck6fp1000 combination.A device history record (dhr) was reviewed and no discrepancies or anomalies were found.For this lot there was a dhr addendum.The addendum was to add ncrus-23936 which was for an undersized neck condition and to add ncrus-23671 which was for oversized thread depth condition.The disposition for both of these nonconformances was accept as is.These should not be related to the reported event.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.

• Brand Name: TRI-LOCK BPS SZ 4 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: 10455532
• Report Number: 1818910-2020-18826
• Device Sequence Number: 3974576
• Product Code: KWA
• UDI-Device Identifier: 10603295001065
• UDI-Public: 10603295001065
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2018
• Device Model Number: 1012-14-040
• Device Catalogue Number: 101214040
• Device Lot Number: CK6FP1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 09/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASR ACETABULAR CUPS 58; ASR TAP SLV ADAP 12/14 -1; ASR UNI FEMORAL IMPL SIZE 51; TRI-LOCK BPS SZ 4 HI OFFSET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 129