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

Model Number	74121154
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	09/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Us legal mdl.It was reported that, after a bhr resurfacing construct had been implanted on the plaintiff left hip on (b)(6) 2009, the plaintiff experienced pain and elevated metal ion levels.A revision surgery was performed on (b)(6) 2020 to treat this adverse event.During this revision surgery, the surgeon noticed that the synovial tissue was somewhat metallic stained.The plaintiff outcome is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that a revision surgery was performed on the patients left hip.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling / instructions for use review could not be performed.The devices would have met manufacturing specifications at the time of production.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The clinical information provided, of the elevated metal ion levels, metallic stained synovial tissue and reactive cyst may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause & probable cause cannot be determined.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.
Additional Manufacturer Narrative
It was reported that left hip revision surgery was performed due to elevated serum metal ion levels.As of today, the implanted devices, all of which were used in treatment, have been requested but have not become available.A review of the historic complaints data for devices reportedly involved in this incident was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the complaint being reopened.As no batch numbers were provided a review of similar failure modes related to the batch could not be performed for the cup or head.Other similar complaints have been identified for the part number and the reported failure mode for the cup and head in this timeframe, and this failure will continue to be monitored through routine monthly complaint trending.Without a provided batch number, the manufacturing records for the devices cannot be reviewed.Should more information be provided at a later date, this task will be reopened and completed.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.A review of historic quality escalations was performed.Following the review, no prior applicable escalation actions were identified.The clinical information provided, reporting pain, elevated metal ions, metallic stained tissue, and little reactive cyst may be consistent with metal debris; however, the clinical root cause cannot be definitively confirmed.It cannot be concluded the reported event/clinical reactions were associated with a mal performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the information provided we cannot further investigate the complaint our investigation remains inconclusive and 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.If the products or additional information become available in the future, this case will be reopened.Based on this investigation the need for corrective and preventative action is not indicated.
Event or Problem Description
It was reported that, after a bhr resurfacing construct had been implanted on the plaintiff left hip on (b)(6) 2009, the patient experienced pain and elevated metal ion levels.A revision surgery was performed on (b)(6) 2020 to treat this adverse event.During this revision surgery, the surgeon noticed that the synovial tissue was somewhat metallic stained, and there was a little reactive cyst behind the cup.The patient's outcome is unknown.

• Brand Name: RESURFACING FEMORAL HEAD 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• 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: 11861462
• Report Number: 3005975929-2021-00278
• Device Sequence Number: 2188416
• Product Code: NXT
• UDI-Device Identifier: 03596010502803
• UDI-Public: 03596010502803
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/07/2023
• 2 Devices were Involved in the Event: 1 2

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 Model Number: 74121154
• Device Catalogue Number: 74121154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/18/2021; 05/22/2023; 06/20/2023; 07/03/2023
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 06/23/2021; 06/07/2023; 06/28/2023; 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 119 KG