MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 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	No Code Available (3191)
Date of Event	09/21/2020
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
Clinical notification received for revision of right total hip to address polyethylene liner wear.Date of implantation: (b)(6) 2005.Date of revision: (b)(6) 2020; (right hip).Treatment: acetabular liner and femoral head were revised.
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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: DUR OPT LPW POLY INS 28/48,50
• Common Device Name: DURALOC OPTION IMPLANTS : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10843065
• Report Number: 1818910-2020-24656
• Device Sequence Number: 3629453
• Product Code: LPH
• UDI-Device Identifier: 10603295065647
• UDI-Public: 10603295065647
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K040544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2020
• 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): 10/30/2020

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: 1599-23-048
• Device Catalogue Number: 159923048
• Device Lot Number: 1904466
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 12/29/2020
• 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: CANCELLOUS BONE SCREW 6.5X35MM; CANCELLOUS BONE SCREW 6.5X45MM; DELTA CER HEAD 12/14 28MM +5; DURALOC OPTION CUP 50MM; SUMMIT POR TAPER SZ3 HI OFF; CANCELLOUS BONE SCREW 6.5X35MM; CANCELLOUS BONE SCREW 6.5X45MM; DELTA CER HEAD 12/14 28MM +5; DURALOC OPTION CUP 50MM; SUMMIT POR TAPER SZ3 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 64