MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 60MM; HIP ACETABULAR CUP

Catalog Number	121701060
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Discomfort (2330); Joint Dislocation (2374)
Date of Event	11/27/2010
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
May 03, 2017: litigation received.Pfs alleges severe pain, dislocation, discomfort, friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused large amounts of toxic cobalt-chromium metal and particles to be released into patient's blood, tissue and bone surrounding the implant.It was also reported that the patient had a revision on (b)(6) 2010 and (b)(6) 2011.It is unknown what components were removed during the revision and it is also unknown if depuy components were implanted.No medical records and laboratory values provided.Update jun 22, 2017: legal medical records received.In addition to what was previously alleged, pfs alleges swelling in left leg.After review of medical records for the mdr reportability, patient was revised due to dislocated antibiotic spacer.Revision notes stated that the wound released a significant amount of collected seronsanguineous fluid mixed with blood.The antibiotic spacer was immediately apparent and was removed.It was previously reported on the litigation that patient underwent surgery on (b)(6) 2010, and on (b)(6) 2011, however ,there were no medical records.Shall there be new information received , another complaint will be created.Added cup and hole eliminator.Product codes and lot numbers were provided.This complaint was updated on jul 5, 2017.
Additional Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary :no device associated with this report was received for examination.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.Depuy considers the investigation closed.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE 100 ACET CUP 60MM
• Common Device Name: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6731772
• Report Number: 1818910-2017-21507
• Device Sequence Number: 13634563
• Product Code: KWA
• UDI-Device Identifier: 10603295008590
• UDI-Public: 10603295008590
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K073504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2017

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: 08/27/2018
• Device Catalogue Number: 121701060
• Device Lot Number: C3DEP1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 09/20/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 96