MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR NEUT 32IDX64OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121932064
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Patient was revised to address wearing of acetabular liner as well as broken of anti-rotational pegs on the liner.Doi: (b)(6) 2006; dor: (b)(6) 2019; unknown affected side.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date of implantation will be retracted as this was reported in error.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot = > y76r61000.Device history batch = > null.Device history review = > no anomalies or deviations were found during the review.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: PINN MAR NEUT 32IDX64OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8777425
• Report Number: 1818910-2019-97991
• Device Sequence Number: 2102945
• Product Code: LPH
• UDI-Device Identifier: 10603295013969
• UDI-Public: 10603295013969
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2019

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 Catalogue Number: 121932064
• Device Lot Number: Y76R61000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 07/18/2019; 07/26/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/24/2019; 07/26/2019
• 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