MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 54MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	74122554
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference :(b)(4).
Event or Problem Description
It was reported that, after a conversion to bhr-tha had been performed on (b)(6) 2012, the patient presented pain.A revision surgery was performed on (b)(6) 2023 to convert to a bhr dual mobility hip: the bhr cup and the anthology stem were retained as were well fixed, while the hemi head 54mm and sleeve were exchanged.Patient's current health status is unknown.
Additional Manufacturer Narrative
It was reported that it was reported that, after a conversion to bhr-tha had been performed on (b)(6) 2012, the patient presented pain.A revision surgery was performed on (b)(6) 2023 to convert to a bhr dual mobility hip: the bhr cup and the anthology stem were retained as were well fixed, while the hemi head 54mm and sleeve were exchanged.Current patient health status is unknown.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the 74122554 hemi head 54mm was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.No additional similar complaints have been identified for the device.This will continue to be monitored via routine trending, however it should be noted that this device is no longer sold.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.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 are required.As no device part and batch numbers were provided for investigation related to the unkn birmingham hip modular head (bhmh) sleeve, a complaint history review, manufacturing record review, or definite escalation actions review could not be performed.If more information is received, this investigation will be reopened.The review of the product's most recent ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed for the birmingham hip modular head (bhmh) sleeve.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions for all birmingham hip modular head (bhmh) sleeve 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 are required.The available medical documents were reviewed.As of the date of this medical investigation, the requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported pain.With the limited information provided, the patient impact beyond the reported revision cannot be determined.No further clinical assessment is warranted at this time.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.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.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: HEMI HEAD 54MM
• 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: 16746730
• Report Number: 3005975929-2023-00025
• Device Sequence Number: 8576237
• Product Code: KWL
• UDI-Device Identifier: 00885556071854
• UDI-Public: 885556071854
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K062408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2023

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: 11/29/2013
• Device Catalogue Number: 74122554
• Device Lot Number: 08LW19930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/15/2023
• Date Device Manufactured: 11/30/2008
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2745-2015
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 105 KG