MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CERAMAX CERAMIC INSERT 36 X 52; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number	121887652
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/19/2018
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 the ceramic insert cracked during surgery.The surgeon got the insert stuck and attempted to hit it to change the position and it cracked on the rim.Surgical delay is 10 mins.
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: no device was received hence the complaint cannot be confirmed.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.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CERAMAX CERAMIC INSERT 36 X 52
• 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: 8249567
• Report Number: 1818910-2019-81001
• Device Sequence Number: 19230862
• Product Code: MRA
• UDI-Device Identifier: 10603295012511
• UDI-Public: 10603295012511
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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: No Information
• Device Catalogue Number: 121887652
• Device Lot Number: 7883804
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR