MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG OXINIUM FEM HD 12/14 32 MM +16; PROSTHESIS, HIP, SEMI-CONSTRAIN, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75100483
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient received a revision surgery due to a subluxation of primary hip several days post-op.The femoral head and the polarstem stem lat.Ti/ha 10 non-cem were explanted.An atlas cup (alternative company) was also explanted.Surgeon implanted size 62 r3 multihole cup with flat 4mm offset liner (36mm head) and size 11 collared polarstem.No blame attributed to smith and nephew implants for revision.Patient outcome is unknown.
Additional Manufacturer Narrative
It was reported that the patient received a revision surgery due to a subluxation of primary hip several days post-operative.A polarstem stem lat.Ti/ha 10 non-cem were explanted, which intent use is in treatment.Smith and nephew has not received the device/ adequate materials to fully evaluate the complaint.The manufacturing documentation did not reveal any deviation which could explain the occurred failure.Additionally, no other complaint can be found for the specific article or batch number, which reports a similar issue.The root cause remains undetermined.At that moment no further actions are planned.The risk of a luxation is mentioned in our current risk management file and our current instruction for use for hip implants 12.23 ed.05/16.If additional clinically relevant materials or the product itself will be received, the complaint will be re-assessed.S+n will monitor this device for similar issues.

• Brand Name: OXINIUM FEM HD 12/14 32 MM +16
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAIN, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• MDR Report Key: 10832873
• Report Number: 9613369-2020-00235
• Device Sequence Number: 3025598
• Product Code: LZO
• UDI-Device Identifier: 07611996118742
• UDI-Public: 07611996118742
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: AS
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2020

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: 02/20/2024
• Device Model Number: 75100483
• Device Catalogue Number: 71343216
• Device Lot Number: B1702678
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 12/13/2020
• 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: HEAD 71343216, LOT 14HM07842
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention