MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 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	Insufficient Information (4580)
Date of Event	01/01/2020
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
Surgeon is ordering a patient specific duraloc hip inlay for a planned revision because of normal and expected pe-wear left side.Doi: (b)(6) 2003, dor: (planned) 2021.There has been no allegation of any product deficiency.
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 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 ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11009323
• Report Number: 1818910-2020-26879
• Device Sequence Number: 753253
• Product Code: LPH
• UDI-Device Identifier: 10603295065647
• UDI-Public: 10603295065647
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 02/23/2021
• 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: UNK HIP ACETABULAR LINER POLY DURALOC.; UNK HIP ACETABULAR LINER POLY DURALOC
• Patient Age: 77 YR