MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 1 STD OFFSET; HIP FEMORAL STEM/SLEEVE

Catalog Number	101204010
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Pain (1994)
Date of Event	03/17/2014
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.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Event or Problem Description
New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint ¿ litigation alleges that patient experienced pain and suffering, additional unforeseen surgeries, and metallosis.Patient is not scheduled for an explantation, but is regularly being monitored for chromium/cobalt ions and hip fraction.Update: 5/21/12 - plaintiff¿s preliminary disclosure form was received, which identified part/lot) information.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.Update rec'd 08/04/2014 - plaintiff¿s preliminary disclosure form was received, which identified dor information.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.The complaint was updated on: 08/06/2014 update rec'd 11/24/2014 - plaintiff¿s preliminary disclosure form was received, which identified dor information from medical records.The dor will be corrected.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.The complaint was updated on: 12/23/2014 update aug 4, 2017: medical records received.After review of the medical records for the mdr reportability, patient was revised to address painful prosthesis and elevated metal levels.Revision notes reported of reactive grayish pseudomembrane.There are no laboratory results provided for the elevated metal ions.Added stem and sleeve due to alleged elevated metal ions this complaint was updated on aug 4, 2017.
Additional Manufacturer Narrative
New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint ¿ litigation alleges that patient experienced pain and suffering, additional unforeseen surgeries, and metallosis.Patient is not scheduled for an explantation, but is regularly being monitored for chromium/cobalt ions and hip fraction.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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 1 STD OFFSET
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6837558
• Report Number: 1818910-2017-23939
• Device Sequence Number: 706093
• Product Code: KWA
• UDI-Device Identifier: 10603295000723
• UDI-Public: 10603295000723
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2017

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 Expiration Date: 06/22/2018
• Device Catalogue Number: 101204010
• Device Lot Number: CY5GY1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 01/16/2018
• 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: 69 YR