MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 PINNACLE DM LINER 58_49; TOTAL HIP JOINT REPLACEMENT PROSTHESIS

Model Number	1218-58-049
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/16/2021
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
The patient was revised due to pain.Doi: (b)(6) 2021, dor: (b)(6) 2021, affected side: left hip.
Additional Manufacturer Narrative
Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received indicated that no patient harm occurred.
Event or Problem Description
With regards to this, please confirm if any of the following information is available: do you confirm that the products will be not sent back to serf? could you specify which devices have been revised? could you send a surgical report and x rays ? please specify the patient¿s age? answers: products will not be sent back to serf.The pinnacle dm liner, bimentum pe liner, articul/eze 28 metal head.No additional information available.77.
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 (b)(4), review of the device history record is unlikely to add value to the complaint investigation regarding an allegation of pain.

• Brand Name: PINNACLE DM LINER 58_49
• Common Device Name: TOTAL HIP JOINT REPLACEMENT PROSTHESIS
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12562499
• Report Number: 1818910-2021-21711
• Device Sequence Number: 1240671
• Product Code: LPH
• UDI-Device Identifier: 10603295520306
• UDI-Public: 10603295520306
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 09/16/2021

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: 1218-58-049
• Device Catalogue Number: 121858049
• Device Lot Number: 9704080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 09/23/2021; 10/27/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 10/11/2021; 10/28/2021
• 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: ARTICUL/EZE BALL 28 +8.5 BL; BI MENTUM PFRK PE LINER 28 49; PINNACLE DM LINER 58_49; ARTICUL/EZE BALL 28 +8.5 BL; BI MENTUM PFRK PE LINER 28 49; PINNACLE DM LINER 58_49
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR