MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 50MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	74122550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a conversion from bhr to bhr-tha had been performed in or around 2011, the patient experienced unspecified symptoms that made necessary an additional intervention on (b)(6) 2022.During this revision surgery, the 50mm bhr hemi head and the 56/50 mm bhr acetabular cup were explanted and replaced with an oxinium femoral head and a competitor¿s acetabular shell and plastic liner.The patient¿s outcome is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3,h6: it was reported that the patient experienced unspecified symptoms that required a revision surgery.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.As no device part and batch numbers were provided for the modular sleeve, a complaint history review could not be performed.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the hemi head.A review of historical complaints data was performed using the part number and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints were identified for the hemi head, however, as the device is no longer sold, no action is to be taken.As no device batch numbers were provided for investigation for the devices concerned, a manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.Without details of the type of symptoms experienced by the patient, it is not possible to evaluate the risk file for the devices.Therefore, a risk management review was not performed.Should further details become available at a later date then the task will be reopened and completed.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions required.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint from a clinical perspective.Without additional information we cannot further investigate or confirm the reported complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: HEMI HEAD 50MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14595312
• Report Number: 3005975929-2022-00374
• Device Sequence Number: 16643441
• Product Code: KWL
• UDI-Device Identifier: 00885556071205
• UDI-Public: 885556071205
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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: 74122550
• 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: 05/09/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2021
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVE; UNKN ECHELON IMPL
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male