MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM -3; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number	71343203
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an echelon stem with oxinium head in a procedure done at ncph on (b)(6) 2018.Dr.Used another company's acetabulum components.This patient had a dislocation reporting to tech & dr.Made the decision to exchange the acetabulum components, again using another company, however he required a smaller sized oxinium head due to using a constrained liner.Nothing wrong with the original head, exchanged due to size requirements only.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and clinically relevant documentation was not provided, therefore a though medical investigation could not be performed.However, the reported off-label use of competitor acetabular components cannot be ruled out as a contributing factor to the reported dislocation for which the surgeon reportedly exchanged acetabular components and the femoral head.No further medical assessment is warranted at this time.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.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.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 32MM -3
• 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: 8326209
• Report Number: 1020279-2019-00510
• Device Sequence Number: 11326274
• Product Code: LZO
• UDI-Device Identifier: 03596010474216
• UDI-Public: 03596010474216
• Combination Product (Y/N): N
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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: 71343203
• Device Lot Number: 17HM09999
• Initial Date Received by Manufacturer: 01/20/2019
• Supplement Date Received by Manufacturer: 01/20/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1