MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DUR BANTAM 10D 22.225X46 LINER; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number	124146526
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that a duraloc 300 series shell (46mm od 124646000) was implanted with the liner 123906000 (neutral 22.225mm id x 46mm od).There was a need to change the liner recently and our sales associate had brought in the 10 degree bantam liner (124146526) and the locking ring (124946503) that goes with it.These however would not fit in the 300 series cup.There was no reported patient consequence.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: this is a duplicate report of 1818910-2019-82925.1818910-2019-84128 is being retracted as it is a report duplication.1818910-2019-82925 will be kept for investigation.

• Brand Name: DUR BANTAM 10D 22.225X46 LINER
• Common Device Name: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 8331101
• Report Number: 1818910-2019-84128
• Device Sequence Number: 11175173
• Product Code: LPH
• UDI-Device Identifier: 10603295019008
• UDI-Public: 10603295019008
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K961186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

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 Catalogue Number: 124146526
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1