MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CERAMAX CERAMIC INSERT 36 X 60; HIP ACETABULAR INSERT/LINER

Catalog Number	121887660
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	09/05/2017
Type of Reportable Event	Serious Injury
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 the surgeon placed the ceramic liner in the cup and positioned it with the ard's lined up.While impacting the ceramic liner it cracked.The surgeon removed all chipped & broken pieces from the patient.He washed out the hip and proceeded to put in another liner.
Additional Manufacturer Narrative
(b)(4).Conclusion and justification status: the complaint state der states that the surgeon placed the ceramic liner in the cup and positioned it with the ard's lined up.While impacting the ceramic liner it cracked.The surgeon removed all chipped & broken pieces from the patient.He washed out the hip and proceeded to put in another liner.A review of complaint databases and review of manufacturing records did not identify any anomalies.The supplier reviewed the product and manufacturing documents and a report was received stating; the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There are no indications of any preexisting material defect.Primary regular metal transfer cannot be found on the insert.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep (b)(4).Device history lot: 429276.Device history review: (b)(4) was manufactured on 26 jun 2013.(b)(4) parts were manufactured per specification and all raw materials met specification.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
Complaint description: der states that the surgeon placed the ceramic liner in the cup and positioned it with the ard's lined up.While impacting the ceramic liner it cracked.The surgeon removed all chipped & broken pieces from the patient.He washed out the hip and proceeded to put in another liner./ | investigation method: / | investigation summary:.

• Brand Name: CERAMAX CERAMIC INSERT 36 X 60
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6914697
• Report Number: 1818910-2017-25903
• Device Sequence Number: 1312213
• Product Code: MRA
• UDI-Device Identifier: 10603295012559
• UDI-Public: 10603295012559
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 09/05/2017

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: 121887660
• Device Lot Number: 4296276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 10/04/2017
• Supplement Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1