MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM XL/+12; PROSTHSIS,HIP,SMICONSTRAIND,METL/CERAMIC/POLYMR,CMNTDONONPOROUS,UNEMNTD

Catalog Number	71343612
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient tripped at work, and heard a "pop" in his hip.The stem broke at the neck as a result of the fall.The stem and head was removed.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A lab analysis indicated bone on-growth was observed in the porous regions of the stem.Scratches and dents observed on the articular surface of the femoral head and near the female taper, on and below the chamfer.Damage was observed on all sides of the femoral neck, on both the head side and stem side.Additional damage was observed on the driver hole, as well as on the anterior & posterior edges of the stem.It can be presumed that most of the driver-hole and lateral/medial stem damage occurred during the removal of the stem.Right or left hand hip was not clearly defined in the product complaint form.Upon examining the fracture surfaces, significant scratching was observed on the outer superior neck surface, near the fracture site, additional sem images were taken of the proximal fracture surface.The specific site of fracture initiation or cause of fracture could not be determined during this investigation.A clinical analysis indicated that it was reported this patient underwent a revision surgery to replace broken stem.The physician reported, ¿the patient tripped at work, and heard a "pop" in his hip.The stem broke at the neck as a result of the fall.¿ the explants, radiographs, nor clinical documents were provided to conduct a thorough analysis of the reported issue.Based on the statement by the physician, ¿the stem broke at the neck as a result of the fall.¿ the future impact to the patient cannot be determined.No further clinical/medical assessment is warranted at this time.Based on this investigation, the need for corrective action is not indicated.No further investigation is 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.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 36 MM XL/+12
• Common Device Name: PROSTHSIS,HIP,SMICONSTRAIND,METL/CERAMIC/POLYMR,CMNTDONONPOROUS,UNEMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7528393
• Report Number: 1020279-2018-00957
• Device Sequence Number: 233239
• Product Code: LZO
• UDI-Device Identifier: 03596010520449
• UDI-Public: 03596010520449
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71343612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/19/2018
• Supplement Report FDA Received Date: 11/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNERGY STEM/UNK
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention