MAUDE Adverse Event Report: DUR OPT LPW POLY INS 28/48,50; DURALOC OPTION IMPLANTS : HIP POLY ACETABULAR LINERS

Model Number	1599-23-048
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
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 instrument has pe wear.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot: a worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: DUR OPT LPW POLY INS 28/48,50
• Common Device Name: DURALOC OPTION IMPLANTS : HIP POLY ACETABULAR LINERS
• MDR Report Key: 12554594
• Report Number: 1818910-2021-21571
• Device Sequence Number: 3990415
• Product Code: LZO
• UDI-Device Identifier: 10603295065647
• UDI-Public: 10603295065647
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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 Model Number: 1599-23-048
• Device Catalogue Number: 159923048
• Device Lot Number: XVL-06
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1