MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE 100 HA ACET CUP 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121711048
Medical Device Problem Codes	Noise, Audible (3273); Separation Problem (4043)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/11/2018
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
It was reported that patient was previously a repeat dislocator.After close to a year of no repeat problems, patient noticed a squeaking noise and was x-rayed.Looked as though she had dislocated again and head was resting on lip of 10 "degress".Liner: during surgery it was found that the liner had fractured in two pieces and possibly had disassociated from the cup while in patient.Noticed damage on various parts of liner, marks on a head from metal on ceramic articulation.Cup was well fixed.Patient was revised to larger cup and larger head.
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.
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 acetabular cup does find evidence to support the reported disassociation event.Product error / contribution to the event is not identified.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 HA ACET CUP 48MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8228976
• Report Number: 1818910-2019-80244
• Device Sequence Number: 13925041
• Product Code: LPH
• UDI-Device Identifier: 10603295009047
• UDI-Public: 10603295009047
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K031495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2018

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 Catalogue Number: 121711048
• Device Lot Number: H74385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/09/2019; 01/28/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 01/22/2019; 02/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Weight: 68