MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CERAMAX CERAMIC INSERT 36 X 56; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number	121887656
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
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
Der states that during a routine left tha replacement, a 56mm pinnacle cup was implanted.No screws were placed in the cup.A ceramax 36x56 liner was inserted after fixation of the pinnacle cup.The surgeon checked to make sure the liner was properly inserted prior to impaction.Upon impaction the liner fractured in several places.The broken liner was removed, and a new 36x56 ceramax liner was inserted.The 2nd liner was impacted and seated correctly.Please check returned fractured liner to make sure it is within proper specifications.Doe: (b)(6) 2018.
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.
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 : the device was returned and failure mode confirmed.The insert had fractured.A review of complaint databases and manufacturing records did not identify any anomalies.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: CERAMAX CERAMIC INSERT 36 X 56
• Common Device Name: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7530526
• Report Number: 1818910-2018-60131
• Device Sequence Number: 1452881
• Product Code: MRA
• UDI-Device Identifier: 10603295012535
• UDI-Public: 10603295012535
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121887656
• Device Lot Number: 8482507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 01/08/2019; 03/25/2019
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 01/28/2019; 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR