MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. PINN MAR +4 NEUT 36IDX56OD; HIP ACETABULAR INSERT/LINER

Model Number	1219-36-456
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	08/15/2016
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
The 36 ceramic head broke.Update oct 5, 2017: litigation record received.In addition to what was previously reported, litigation alleges pain, discomfort and failure of acetabular liner.Added complainant information.Added unknown liner.This complaint was updated on oct 13, 2017.Update oct 21, 2017: pfs and medical record received.In addition to what were previously alleged for mdr reportability, medical records reported that patient had an unusual sensation, popping in the hip, and unable to bear his weight.Revision notes reported that the surgeon found broken bits of ceramic, broken ceramic head, dislocated hip, scratches on the trunnion, and wearing of the head and liner.This complaint was updated on oct 27, 2017.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.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 will be filed as appropriate.

• Brand Name: PINN MAR +4 NEUT 36IDX56OD
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7002159
• Report Number: 1818910-2017-28046
• Device Sequence Number: 19206493
• Product Code: LPH
• UDI-Device Identifier: 10603295014720
• UDI-Public: 10603295014720
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2017

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: 11/26/2015
• Device Model Number: 1219-36-456
• Device Catalogue Number: 121936456
• Device Lot Number: E67GK1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 11/04/2017
• Supplement Report FDA Received Date: 06/12/2020
• 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: 48 YR