MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122544

Device Problem Biocompatibility (2886)

Patient Problems Metal Related Pathology (4530); Unequal Limb Length (4534)

Event Date 04/26/2022

Event Type  Injury  

Event Description

It was reported that, the plaintiff underwent a r3 total hip arthroplasty (right hip) on (b)(6) 2010 due to hip dysplasia.Sever deformities of acetabulum and proximal femur with complete loss of normal articular cartilage and a 30 mm limb length discrepancy on the right side.The patient, due to his continued pain and disability, decided to proceed with a revision surgery of the right hip.It was noticed osteolysis on x-ray and on radiological image a failure of the tha with mom articulation with elevated metal ions.The revision surgery was performed on (b)(6) 2022 where the bhr hemi-head was explanted.Intraoperatively, necrotic tissue was seen.After the procedure the patient was taken to the recovery room in stable condition.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: it was reported that a right hip revision surgery was performed due to osteolysis and elevated metal ions, necrotic tissue was seen intraoperatively.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the devices concerned.A review of historical complaints data was performed using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints were identified for the hemi head.No other similar complaints were identified for the modular sleeve.However, as the devices are no longer sold, no action is to be taken.As no device batch numbers were provided for investigation, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.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 reported elevated metal ions, necrotic tissue and minimal staining of the trunnion may be consistent with metal debris and trunnionosis, the clinical root cause of the reported clinical reactions/event cannot be confirmed.It should be noted however, the patients¿ multiple previous operative interventions, and significant deformities cannot be ruled out as contributing factors to the reported events.Based on the available information we can confirm the reported complaint, however without further information 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.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.H6: clinical symptoms updated.

• Brand Name: HEMI HEAD44MM
• Type of Device: 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: 15127070
• MDR Text Key: 296839153
• Report Number: 3005975929-2022-00442
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 00885556070994
• UDI-Public: 00885556070994
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74122544
• Device Catalogue Number: 74122544
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PN: 71332520 / LOT: 09LT37261; PN: 71332525 / LOT: 09LM04868; PN: 71332530 / LOT: 10GT44451; PN: 71335556 / LOT: 09KM03513; PN: 71336500 / LOT: 10HM10097; PN: 74222200 / LOT: UNKNOWN.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Male