MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 NEUT 32IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-450
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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
There was an implant of a corail/pinnacle last week and the surgeon mentioned that the 32 +4mm neutral liner that he used looked different to normal.The theatre sister thought nothing more of it and the case went well.Later when she scanned the implants into their system for njr purposes the liner was coming up as a +4mm 10 degree.
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: root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 32IDX50OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9553659
• Report Number: 1818910-2020-00593
• Device Sequence Number: 3096318
• Product Code: LPH
• UDI-Device Identifier: 10603295014324
• UDI-Public: 10603295014324
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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 Model Number: 1219-32-450
• Device Catalogue Number: 121932450
• Device Lot Number: J28T11
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1