MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR(R) EXTRACTOR BARREL; HIP INSTRUMENT

Catalog Number APA0-0001

Device Problem Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 09/15/2017

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trends will be evaluated.

Event Description

Allegedly the fork of the extractor that is suppose to rest under the rim of the adaptor was stripped/warped prior to use.Noticed during revision procedure when the extractor would not appropriately catch the rim of the adaptor.Thus we were unable to move modular neck successfully.Kit number: (b)(4).

• Brand Name: PROFEMUR(R) EXTRACTOR BARREL
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 6893334
• MDR Text Key: 87321978
• Report Number: 3010536692-2017-01261
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: APA0-0001
• Device Lot Number: 391878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/20/2017
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 09/18/2017
• Supplement Dates FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 75