MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 44/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74122152
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hip Fracture (2349); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
Us legal: bilateral patient.It was reported that after the patient underwent a revision surgery of the left hip on (b)(6) 2012, the patient underwent another revision surgery of the left hip on (b)(6) 2021 due to mechanical complication of prosthetic hip implant, osteolysis, metallosis and periprosthetic fracture.The primary left bhr was performed on (b)(6) 2009.The patient status is unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, with the information provided the clinical root cause of the reported elevated metal ions and intraoperative findings of metallosis, trunnionosis and greater trochanteric fracture cannot be confirmed.However, the surgical technique indicates the acetabular component is to be impacted with 15-20° of anteversion.The implantation operative report indicated the acetabular component was implanted at about 20 to 25 degrees of anteversion.It is unknown if the increased anteversion of the acetabular component led to the reported elevated metal ions and intraoperative findings of metallosis and trunnionosis.It cannot be concluded that the reported events/ clinical reactions were associated with a mal performance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that fracture, metal sensitivity reactions and/or allergic reactions to foreign materials has been identified as adverse events in primary and revision surgery.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include surgical technique, excessive forces applied to the implant, damaged product, implant corrosion or wear.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
H9: z-2745-2015 through z-2747-2015.H3, h6: it was reported that left hip revision surgery was performed.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 acetabular cup was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and 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.No other similar complaints were identified to involve this batch.Other similar complaints were identified for the part number and the reported failure mode.However, as the device is no longer sold, no action is to be taken.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.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.The =46mm bhr resurfacing system has been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.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 required.The available medical documents were reviewed.With the information provided the clinical root cause of the reported elevated metal ions and intraoperative findings of metallosis, trunnionosis and greater trochanteric fracture cannot be confirmed.However, the surgical technique indicates the acetabular component is to be impacted with 15-20° of anteversion.The implantation operative report indicated the acetabular component was implanted at about 20 to 25 degrees of anteversion.It is unknown if the increased anteversion of the acetabular component led to the reported elevated metal ions and intraoperative findings of metallosis and trunnionosis.It cannot be concluded that the reported events/ clinical reactions were associated with a mal performance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.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: ACETABULAR CUP HAP SIZE 44/52
• 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: 13896919
• Report Number: 3005975929-2022-00085
• Device Sequence Number: 4391379
• Product Code: NXT
• UDI-Device Identifier: 03596010552280
• UDI-Public: 3596010552280
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/30/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2012
• Device Catalogue Number: 74122152
• Device Lot Number: 07HW12949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 04/21/2022; 05/08/2024; 09/20/2024
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 06/10/2022; 05/10/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2007
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male