MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +4; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number	71342804
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to oxinium head separated from the trunion on the size 1 anthology stem and did not dislodge from the zimmer constrained liner.
Additional Manufacturer Narrative
The associated oxinium femoral head was returned and evaluated.The femoral head was received alongside zimmer products such as liner, retaining ring and three screws.A lab analysis was performed only on the smith and nephew femoral head.During this investigation, it was indicated that the femoral head showed scratches and dings on the articulating polished surface and on the rim near the female taper, some breaking the oxide layer.It is not apparent how or when the scratches and dings occured.It should be noted that the smith and nephew femoral head is paired with zimmer products, which is considered off label use.The dimensional evaluation performed on the femoral head indicated the relevant features were found to be within specifications.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: OXINIUM FEM HD 12/14 28MM +4
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8483296
• Report Number: 1020279-2019-01382
• Device Sequence Number: 13943671
• Product Code: LZO
• UDI-Device Identifier: 03596010474162
• UDI-Public: 03596010474162
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71342804
• Device Lot Number: 18MM07735
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention