MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN LNR CON +4 NEUT 40IDX62OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS

Catalog Number	121840662
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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
Constrained liner broke while the surgeon was trying to get the femoral head in the liner.
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.Product complaint #: (b)(4).Investigation summary: examination of the returned liner confirms the reported observation.The root cause is attributed to inadvertent use error.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.Device history lot: null.Device history batch: null.Device history review: null.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.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).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.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN LNR CON +4 NEUT 40IDX62OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8717599
• Report Number: 1818910-2019-96384
• Device Sequence Number: 2212244
• Product Code: KWZ
• UDI-Device Identifier: 10603295012184
• UDI-Public: 10603295012184
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121840662
• Device Lot Number: J14X77
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 07/15/2019; 08/27/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/29/2019; 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1