MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DURALOC SECTOR SERIES 50OD; DURALOC IMPLANT : HIP METAL ACETABULAR CUPS

Model Number	1245-80-056
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
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.(b)(4).
Event or Problem Description
Size issue.It was reported that during the total hip replacement operation, used 50mm trial, it was ok, but after insert the implant, it was smaller than the trial as the photos and video show.Another device (52mm) was used to complete the surgery.There were no adverse consequences to the patient.Please refer to the attached photos of the defect product.No additional information could be provided.
Additional Manufacturer Narrative
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 heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not bsynthes 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.Product complaint # : (b)(4).Investigation summary: no products were returned for examination.We were provided with photographs of both the trial and the implant being measured.The photographs were passed on to our design team for examination.The complaint investigation does not indicate a design error for compliant products used per the surgical technique.The measurements provided do not indicate any product defects.However, as the measurements are not verified it cannot be confirmed beyond doubt that the products were compliant.Based on the information provided it is suspected that the surgical technique was not adhered to as a 50 mm shell trial was used after acetabular preparation with a 50 mm grater head.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DURALOC SECTOR SERIES 50OD
• Common Device Name: DURALOC IMPLANT : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 9498404
• Report Number: 1818910-2019-124247
• Device Sequence Number: 208832
• Product Code: LPH
• UDI-Device Identifier: 10603295019657
• UDI-Public: 10603295019657
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/03/2019

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 Model Number: 1245-80-056
• Device Catalogue Number: 124580056
• Device Lot Number: D18082972
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1