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

Catalog Number	74122554
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377); Metal Related Pathology (4530); Insufficient Information (4580); Medical device site infection (4845); High metal ion levels (4847)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference number: (b)(4).
Event or Problem Description
It was reported that, after a bhr-tha system had been implanted on an unspecified date, the plaintiff experienced an unspecified adverse event that was addressed via revision surgery on (b)(6) 2022.No additional information was provided.
Additional Manufacturer Narrative
H3, h6: it was reported that a revision surgery was performed due to an unspecified adverse event.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 investigation, a complaint history review, manufacturing record review, or definite escalation actions review could not be performed.A review of the product¿s instructions for use was not possible due to limited information about the details of the event and device.Without basic part details or an alleged failure mode, no risk file review is possible.No further actions are required at this time.If more information is received, this investigation will be reopened.A review of historic escalation actions for all modular heads 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 requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the unspecified complications.With the limited information provided, the patient impact beyond the reported revision cannot be determined.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.
Additional Manufacturer Narrative
B5: describe event or problem, h4: device manufacture date, g5: pma/510(k)# d4: catalog#, lot#, expiration date, unique identifier (udi)#, d1: brand name, d2a: common device name, d2b: procode, d11: concomitant medical products and therapy dates and b7: other relevant history, including preexisting medical conditions.A2: age or date of birth and d6: if implanted, give date h6: health effect - clinical code and medical device problem code.
Event or Problem Description
It was reported that after a total hip arthroplasty performed on (b)(6) 2009, the patient shows elevated metal ions in his blood and elevated c-reactive protein (crp) and esr and aspiration of the right hip showed over 100,000 with cells with a positive culture.These adverse events were treated via revision surgery that was performed on (b)(6) 2022.During the revision surgery was noticed significant metallosis involving the soft tissue around the greater trochanter, there was also significant osteolysis due to this metallosis of the proximal femur.All implants were explanted and replace with a prostalac system (competitor implants).No further complications were reported.
Additional Manufacturer Narrative
H3, h6: it was reported that a right hip revision surgery was performed due to elevated metal ions in blood, elevated c-reactive protein (crp), infection, significant metalosis and osteolysis of the proximal femur.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 head and the cup, and this failure will continue to be monitored for the cup.This will continue to be monitored via routine trending for the head and the sleeve, however it should be noted that these 2 devices are 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.The elevated metal ions, esr and crp levels (reported to be elevated) however, neither the levels nor the lab reports were provided.The clinical root cause of the infection cannot be confirmed; however, the reported infection is highly likely of an exogenous nature.The clinical root cause of the reported metalosis, prosthetic joint infection and subsequent revision cannot be definitively concluded.It cannot be concluded the reported clinical reactions were associated with a mal performance of the implant or implant failure.The patient impact beyond the reported events cannot be determined with the limited 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 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: 16935902
• Report Number: 3005975929-2023-00083
• Device Sequence Number: 5730930
• Product Code: KWL
• UDI-Device Identifier: 00885556071854
• UDI-Public: 885556071854
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/01/2023
• 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 Expiration Date: 04/28/2012
• Device Catalogue Number: 74122554
• Device Lot Number: 07DW11536
• 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: 04/23/2023
• Supplement Date Received by Manufacturer: 06/06/2023; 06/21/2023; 07/31/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 06/06/2023; 06/26/2023; 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2007
• 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: ACETLR CUP HAP 60MM W/ IMPTR, LOT#:080190.; MODULAR SLEEVE -4MM 12/14, LOT#:07LW14957.; SYN POR PLUS HA SO STEM SZ 16, LOT#:08LM04779A.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male