MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 DELTA CER HEAD 11/13 32MM +3; HIP CERAMIC FEMORAL HEADS

Catalog Number	136532220
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/28/2018
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
Ceramic head and insert breakage.The initial that was implemented on (b)(6) 2012.No anomaly was occurred during procedure.On (b)(6) 2018 the hip of patient felt pain and patient returned hospital for check.It indicated ceramic head and insert broke in x-ray test.The revision surgery will be planed to implement on (b)(6) 2018.Now patient is under monitoring at hospital.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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.

• Brand Name: DELTA CER HEAD 11/13 32MM +3
• Common Device Name: HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7457720
• Report Number: 1818910-2018-58208
• Device Sequence Number: 1092447
• Product Code: LZO
• UDI-Device Identifier: 10603295033417
• UDI-Public: 10603295033417
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2018

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 Catalogue Number: 136532220
• Device Lot Number: 3175953
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 86