MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM XL/+12; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number	71343612
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two closed reductions were performed on (b)(6) 2017 and (b)(6) 2017 on the right hip requiring a revision surgery on (b)(6) 2017.No delay to procedure reported.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and the dislocations may have been caused by the ¿extremely large fluid collection and hematoma with the fluid volume being reported at over a liter.As for the infection that was discovered but not named/identified, was most likely hematogenous in nature as it was discovered with the 1st revision and 8 years after the primary surgery.It is unknown if the combination of components contributed to the dislocations.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
Additional Manufacturer Narrative
The associated complaint devices were not returned.(b)(4) - the clinical information provided, of the pain, metallosis, a large pseudotumor and extensive bone loss, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.¿ it is unknown what impact that his congenital bone deformity in his right hip had on the wear of the bhr components.(b)(4) ¿ the root cause of the dislocations cannot be concluded with the information provided.(b)(4)¿ the dislocations may have been caused by the ¿extremely large fluid collection and hematoma with the fluid volume being reported at over a liter.As for the infection that was discovered but not named/identified, was most likely hematogenous in nature as it was discovered with the 1st revision and 8 years after the primary surgery.It is unknown if the combination of components contributed to the dislocations.The root cause of the continued dislocations could have been the continuing build-up of fluid and the formation of heterotopic ossification.The root cause for the ¿heterotopic ossification¿ cannot be concluded but some patients can be genetically predisposed it is a known complication of joint surgeries and is related to the procedure and not the device.This revision did not involve any smith and nephew components.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: OXINIUM FEM HD 12/14 36 MM XL/+12
• 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: 8362435
• Report Number: 1020279-2019-00751
• Device Sequence Number: 11220761
• Product Code: LZO
• UDI-Device Identifier: 03596010520449
• UDI-Public: 03596010520449
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2019

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 Expiration Date: 10/18/2025
• Device Catalogue Number: 71343612
• Device Lot Number: 15KM15122
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 01/30/2019; 12/09/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 10/24/2019; 12/11/2019
• 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