MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 60MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74120160
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	01/01/1900
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the plaintiff exhibited elevated metal ion levels in blood after a left hip bhr primary surgery (about 20 mcg/l).No revision surgery or any other medical intervention has been indicated for the patient´s left hip, however, the patient underwent a right hip revision surgery due to metallosis on (b)(6) 2021 (covered under case-(b)(4)).This case was created because we can not rule out the contribution of the left hip bhr system in the alleged elevation of metal ion levels.The primary left hip bhr surgery was performed on (b)(6) 2010.
Additional Manufacturer Narrative
H3, h6.It was reported that the patient exhibited elevated metal ion levels in blood after a left hip bhr primary surgery (about 20 mcg/l).No revision surgery or any other medical intervention has been indicated.As no device batch numbers were provided for investigation for the acetabular cup and the femoral head, a manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the acetabular cup and femoral head.A review of historical complaints data was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.Similar complaints have been identified for the part number and the reported failure mode for both devices and this will continue to be monitored.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.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.With the information provided, the clinical root cause of the reported elevated metal ions and mild symptoms cannot be confirmed.However, the reported ¿metallosis¿ of the contralateral hip cannot be ruled out as a contributing factor to the elevated metal ions.The patient impact beyond the reported events cannot be determined.No further clinical assessment is warranted at this time.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.

• Brand Name: ACETLR CUP HAP 60MM W/ IMPTR
• 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: 14549297
• Report Number: 3005975929-2022-00371
• Device Sequence Number: 12000942
• Product Code: NXT
• UDI-Device Identifier: 03596010502612
• UDI-Public: 03596010502612
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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 Model Number: 74120160
• Device Catalogue Number: 74120160
• 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: 05/05/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 07/22/2022
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male