MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CERAMAX CERAMIC INSERT 36 X 54; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Model Number	1218-87-654
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/04/2021
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 surgeon said he was unsure if the liner was disassociated intraoperatively or became disassociated postoperatively.The surgeon said the patient wanted his hip revised because of pain and lack of motion.The surgeon explained a 54x36 ceramax liner.The surgeon said the liner was fractured.The surgeon trialed a 54x36 +4 10 degree and a 36 x+8.5 ceramic biology ts ceramic head and the surgeon said hip stability and leg length were acceptable.The surgeon asked the nurse to open the same implants matching the trials that were used.The hospital took possession of all explanted items.The surgeon said that he feels the broken pieces were retrieved from the patient.Doi: (b)(6) 2016 dor: (b)(6) 2021 affected side: left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A review of the device manufacturing records found no related deviations or anomalies.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.Device history lot: protocols and certificate of conformance were reviewed.The quality documents show that the values obtained on the ceramic liner are according to specifications valid at the time of production.The component properties and the microstructure as obtained from the quality documents fulfill the requirements as specified at the time of production.There are no indications of any pre-existing material defect.Device history review: protocols and certificate of conformance were reviewed.The quality documents show that the values obtained on the ceramic liner are according to specifications valid at the time of production.

• Brand Name: CERAMAX CERAMIC INSERT 36 X 54
• Common Device Name: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11836536
• Report Number: 1818910-2021-10491
• Device Sequence Number: 19780498
• Product Code: MRA
• UDI-Device Identifier: 10603295012528
• UDI-Public: 10603295012528
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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 Model Number: 1218-87-654
• Device Catalogue Number: 121887654
• Device Lot Number: 8087972
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CERAMAX CERAMIC INSERT 36 X 54; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR