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

Catalog Number	121887652
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
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
The rim of the ceramax ceramic insert 36 x 52 shattered after the third mallet blow with the 36 mm cup impactor.The ceramic insert was placed squarely into the acetabular cup with the suction cup technique prior to impaction.Broken insert was removed, the area lavaged, and a new polyethylene insert was implanted.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.

• Brand Name: CERAMAX CERAMIC INSERT 36 X 52
• Common Device Name: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7911952
• Report Number: 1818910-2018-70624
• Device Sequence Number: 1914316
• Product Code: MRA
• UDI-Device Identifier: 10603295012511
• UDI-Public: 10603295012511
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2018

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: 121887652
• Device Lot Number: 8723620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 12/20/2018; 12/21/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 12/20/2018; 12/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Weight: 50