MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM -3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71343603

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2018

Event Type  Injury  

Event Description

It was reported a medical intervention was performed because after surgery, it was noticed a piece of the instrument was missing.X-rays were performed and they showed missing piece was inside the patient.Then dr had to re-open the tensor, removed the head and stem, retrieve the washer, and reinserted the stem and head new head was used.

Manufacturer Narrative

The associated oxinium femoral head was not returned for evaluation.A clinical evaluation noted that details of the circumstances around broken broach handle were not provided.Oftentimes, the application of excessive force or over-use of certain surgical instruments has been associated with implant damage.There is no information concerning the patient¿s current condition, however the procedure was reported as completed without additional incidence.No further clinical assessment is warranted.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.No further investigation warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: OXINIUM FEM HD 12/14 36 MM -3
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7875127
• MDR Text Key: 120235423
• Report Number: 1020279-2018-01803
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010000675
• UDI-Public: 03596010000675
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

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: Health Professional
• Device Catalogue Number: 71343603
• Device Lot Number: 18EM07641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 08/21/2018
• Supplement Dates FDA Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention