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

Catalog Number	74122550
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a bhr tha surgery of the left hip performed on (b)(6) 2009, the patient experienced metallosis from a metal-on-metal prosthesis with an elevated serum cobalt / chromium levels as well as a pseudotumor on mri.This condition was treated by performing a revision surgery of the left hip on (b)(6) 2023, during which the modular head and sleeve were explanted and replaced with a smith and nephew dual mobility insert and an oxinium femoral head.After the surgery, the patient was transferred to the recovery room in stable condition.No further complications reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that, after a bhr total hip arthroplasty surgery of the left hip the patient experienced metallosis from a metal-on-metal prosthesis with an elevated serum cobalt / chromium levels as well as a pseudotumor on mri.This condition was treated by performing a revision surgery of the left hip during which the modular head and sleeve were explanted and replaced with a smith and nephew dual mobility insert and an oxinium femoral head.After the surgery, the patient was transferred to the recovery room in stable condition.No further complications reported.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 alleged devices 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 cup and head, and no other similar complaints have been identified for the sleeve.This will continue to be monitored for the cup and will continue to be monitored via routine trending for the head and sleeve, however it should be noted that these 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.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 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: 17953075
• Report Number: 3005975929-2023-00152
• Device Sequence Number: 6799528
• Product Code: KWL
• UDI-Device Identifier: 00885556071205
• UDI-Public: 885556071205
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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: 07/30/2013
• Device Catalogue Number: 74122550
• Device Lot Number: 08GW18099
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/06/2023
• Date Device Manufactured: 07/31/2008
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETLR CUP HAP 56MM W/ IMPTR, LOT#:091480; ANTHOLOGY HO POROUS SZ 9, LOT#:08MM03953; MODULAR SLEEVE {} PLUS 0MM 12/14, LOT#:07LW14554
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male