MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120156
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Metal Related Pathology (4530)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after the plaintiff underwent a left metal-on-metal bhr performed on (b)(6) 2012, the patient experienced pain for years, described as sharp and aches.It is worse with weightbearing activities.Patient also mentioned that he has experienced several dislocations per year.He also experienced swelling, a trendelenburg limp, and was concerned about x-rays changes.Metal ions levels were significantly elevated also and mri confirmed abductor destruction and a large pseudotumor.A revision surgery was performed on (b)(6) 2024.There was significant metal reaction fluid that was irrigated from the hip joint.There was no discernible posterior capsule.A significant amount of necrotic muscle was noticed, including the abductors, vastus lateralis and rectus.The greater trochanter was completely devoid of any abductor attachment.An extensive debridement involving the superficial fascial and deep layers was done.A significant amount of abductor musculature was excised, as well as posterior capsular structure.The hip was dislocated, the proximal femur was exposed and the modular head was removed.Then, the acetabular component was exposed, was noticed to be retroverted but well fixed, and was also removed.The synergy stem was well fixed in appropriate anteversion and was retained.The acetabular and head components were replaced for a dual mobility construct.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3,h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
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 alleged devices.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 have been identified for the cup.This failure will continue to be monitored via routine trending.As no device batch numbers were provided for investigation, manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The review of the most recent 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, no prior applicable escalation actions were identified.No further escalation actions are required.The available medical documents were reviewed.A clinical root cause could not be determined.The pain, elevated metal ions, pseudotumor and altr are consistent with the grossly retroverted but well-fixed acetabular component as this can lead to accelerated wear of the components as well as the multiple dislocations leading to metal debris.However, without immediate post-implantation and subsequent imaging initial acetabular placement and/or migration cannot be confirmed.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.
Additional Manufacturer Narrative
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 alleged devices.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 have been identified for the cup.This failure will continue to be monitored via routine trending.As no device batch numbers were provided for investigation, manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The review of the most recent 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, no prior applicable escalation actions were identified.No further escalation actions are required.The available medical documents were reviewed.A clinical root cause could not be determined.The pain, elevated metal ions, pseudotumor and altr are consistent with the grossly retroverted but well-fixed acetabular component as this can lead to accelerated wear of the components as well as the multiple dislocations leading to metal debris.However, without immediate post-implantation and subsequent imaging initial acetabular placement and/or migration cannot be confirmed.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: ACETLR CUP HAP 56MM 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 21993742
• Report Number: 3005975929-2025-00041
• Device Sequence Number: 8480508
• Product Code: NXT
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2026

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 Catalogue Number: 74120156
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 06/06/2025; 05/29/2026
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/10/2025; 06/08/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 213 LB