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

Model Number	1218-87-652
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/27/2021
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
It was reported that the surgeon said the patient complained of pain in her hip.He believed the cup may be loose, and wanted to remove it and replace with a revision cup.After removing the liner and screws he inspected the cup and found that the cup was not loose.He implanted new screws, head and a constrained liner.He was unable to get the locking ring to seat on the constrained liner due to visualization and decided to remove it.He replaced it with a new +4, 10 degree liner and appropriate size head.Doi: (b)(6) 2018, 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.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 for allegations of pain a device manufacturing (mre) review will not be performed even when product/lot information is known.Per wi-3430, review of the device history record is unlikely to add value to the complaint investigation regarding an allegation of pain.

• 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 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12820648
• Report Number: 1818910-2021-25195
• Device Sequence Number: 4906206
• Product Code: MRA
• UDI-Device Identifier: 10603295012511
• UDI-Public: 10603295012511
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1218-87-652
• Device Catalogue Number: 121887652
• Device Lot Number: 8586444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CERAMAX CERAMIC INSERT 36 X 52; DLT TS CER HD 12/14 32MM +5; DLT TS CER HD 12/14 36MM +8.5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN LNR CON +4 10D 32IDX52OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female