MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 48MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	74122548
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a total hip arthroplasty in the left hip was performed on (b)(6) 2013 due to arthritis, the plaintiff presented an adverse local tissue reaction.The adverse event was treated with a revision surgery on (b)(6) 2022 where the femoral head and head sleeve were explanted.During the surgery, a thorough synovectomy was done to remove the adverse local tissue reaction.The plaintiff had quite a bit of bone loss around the femoral stem missing the majority of his greater trochanter.At the end of the surgery, the plaintiff was taken to recovery in stable condition.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Section h3, h6: it was reported that a left hip revision surgery was performed due to adverse local tissue reaction.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 devices concerned was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the hemi head and the cup, and this failure will continue to be monitored for the cup.This will continue to be monitored for the hemi head 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.The available medical documents were reviewed.Although the large thick collection of fluid almost the consistency of a pudding may be consistent with the reported adverse local tissue reaction (altr), the clinical root cause cannot be confirmed with the information provided.It cannot be concluded the altr was related to a mal performance of the implant or implant failure.The patient impact beyond the altr and revision cannot be determined with the information provided.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.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.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 48MM
• 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: 16632452
• Report Number: 3005975929-2023-00021
• Device Sequence Number: 17931982
• Product Code: KWL
• UDI-Device Identifier: 00885556071847
• UDI-Public: 885556071847
• 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: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 74122548
• Device Lot Number: 10FW05446
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/28/2023
• Date Device Manufactured: 06/01/2010
• 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: 54MM BHR ACETABULAR CUP, LOT#: 10DW26634.; BHR MODULAR HEAD SLEEVE +0MM, LOT#:10BW25769.; SYNERGY POROUS HIGH OFFSET FEMORAL COMPONENT SIZE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 102 KG