MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DURALOC SECTOR SERIES 48OD; DURALOC IMPLANT : HIP METAL ACETABULAR CUPS

Model Number 1245-80-055

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

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.

Event Description

Size issue.It was reported that during the surgery of total hip arthroplasty, used 48#trial, it was ok, but 48#implant, it was small.Used 50# to complete surgery.There were no adverse consequences to the patient.After surgery, the customer measured the trial and implant, found the implant was smalled than trial as the photos show.

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 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.Product complaint # : (b)(4).Investigation summary: no products were returned for examination and it was reported on the complaint form that the product had been discarded.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 event description states that a size 50 mm shell had to be used to complete surgery after initially trying to implant a size 48 mm shell.The duraloc surgical technique indicates use error when selecting acetabular grater, trial and shell sizes may lead to the complaint events.However, without knowing the size of the last reamer used, use error cannot be confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DURALOC SECTOR SERIES 48OD
• Type of Device: DURALOC IMPLANT : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9560204
• MDR Text Key: 188899179
• Report Number: 1818910-2020-00950
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295019640
• UDI-Public: 10603295019640
• Combination Product (y/n): N
• PMA/PMN Number: K961186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

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
• Device Operator: Health Professional
• Device Model Number: 1245-80-055
• Device Catalogue Number: 124580055
• Device Lot Number: D18040175
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1