MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP SHELL TI-PLASMA/HA 53 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	75100441
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	06/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, after thr surgery had been performed on (b)(6) 2017, the patient experienced a ground-level fall and suffered a right hip periprosthetic acetabular fracture.This adverse event was solved by revision surgery on (b)(6) 2021 in which a polarcup shell ti-plasma/ha 53 non-cem, a polarcup xlpe insert 53/28 non-cem and a oxinium fem hd 12/14 28mm +8 were explanted and the redapt stem remained in place.Current health status of patient is unknown.
Additional Manufacturer Narrative
H10: h3, h6: it was reported that, after total hip replacement surgery had been performed on (b)(6) 2017, the patient experienced a ground-level fall and suffered a right hip periprosthetic acetabular fracture.This adverse event was solved by revision surgery on (b)(6) 2021 in which a polarcup shell ti-plasma/ha 53 non-cem, a polarcup xlpe insert 53/28 non-cem and a oxinium fem hd 12/14 28mm +8 were explanted and the redapt stem remained in place.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The complaint history review for the complaint device revealed no additional complaints for the affected batch nor additional complaints for the same product number over the past 12 months with similar failure mode.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The instructions for use (lit.No.12.23, ed.03/21) states "hip fracture" of the component as a ¿potential adverse device effect¿ in combination with the implantation of a hip prosthesis.The available medical documents were reviewed.After ground-level fall, x-ray on (b)(6) 2021 showed right hip fracture, requiring revision of acetabular components on (b)(6) 2021.The patient impact was reported right hip fracture and subsequent revision.The event was noted as resolved.There is no evidence that the reported devices failed to meet manufacturing specifications upon release for distribution.A definitive root cause cannot be determined, however, the ground-level fall cannot be discarded as the most reasonable factor which contributed to the periprosthetic acetabular fracture.There is no need for further actions.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: POLARCUP SHELL TI-PLASMA/HA 53 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18271399
• Report Number: 9613369-2023-00223
• Device Sequence Number: 19821979
• Product Code: LZO
• UDI-Device Identifier: 07611996118322
• UDI-Public: 07611996118322
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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: 12/04/2018
• Device Catalogue Number: 75100441
• Device Lot Number: A1140440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71342808 / LOT: 17CM06163; PN: 75018958 / LOT: B1610161
• Patient Age: 79 YR
• Patient Sex: Female