MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DUR BANTAM 10D 22.225X46 LINER; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Model Number	1241-46-526
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Duraloc enduron liner is worn, need to be replaced.Doi: (b)(6) 2013.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Available xray evidence was reviewed.Based in attached photographic evidence, the head of the implant is positioned closer to one of the sides of the cup implant, indicating the liner has worn.The reported condition can be confirmed.A potential cause cannot be determined with the provided information.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot = > a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.
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 there was no surgical delay and the affected side involved in this event was the left side.

• Brand Name: DUR BANTAM 10D 22.225X46 LINER
• Common Device Name: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14042877
• Report Number: 1818910-2022-06340
• Device Sequence Number: 17717295
• Product Code: LPH
• UDI-Device Identifier: 10603295019008
• UDI-Public: 10603295019008
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K961186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2022

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: 1241-46-526
• Device Catalogue Number: 124146526
• 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: 03/23/2022
• Supplement Date Received by Manufacturer: 06/09/2022; 06/21/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 06/09/2022; 06/21/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DURALOC BANTAM ACET CUP 46 OD.
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 85 KG