MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122158

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Arthritis (1723); Infiltration into Tissue (1931); Discomfort (2330); Inadequate Osseointegration (2646); Joint Laxity (4526); Metal Related Pathology (4530)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

Us legal mdl.It was reported that, after a bhr construct had been implanted on (b)(6) 2018, the plaintiff experienced severe pain, discomfort, inflammation around the hip implants, elevated blood metal ion levels, and metallosis.This event is an outgoing issue that started on (b)(6) 2021.The hip has not been revised yet but is planned to be revised.There is no confirmation about date of the revision surgery.The plaintiff current health status is unknown.

Manufacturer Narrative

It was reported that a bhr construct had been implanted in the patient's right hip.No revision surgery had been performed.The devices, which were used in treatment, remain implanted in the patient and therefore cannot be evaluated, additional information has been requested for this complaint but has not become available without definitive lot numbers, a complete complaint history review cannot be performed for the devices involved.As no device batch numbers were provided for investigation, a manufacturing record review and device labelling / ifu review could not be performed.All of the devices would have met manufacturing specifications at the time of production.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical information has been reviewed.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (pain, discomfort, inflammation, elevated blood metal ion levels, and metallosis) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on the results of this investigation, the need for corrective or preventative action is not indicated.

Manufacturer Narrative

H10: additional information in a2, a3, b5, b7, d1, d4, d6b, g4 and h4.H11: corrected information in h6 (health effect - clinical code, health effect - impact code and medical device problem code).

Event Description

It was reported that, after a bhr construct had been implanted on (b)(6) 2018, the plaintiff experienced severe pain, discomfort, inflammation around the hip implants, and elevated blood metal ion levels.This event is an issue that started on (b)(6) 2021.The plaintiff initially had resolution of pain after surgery, but back in (b)(6) 2021 he developed new onset groin pain.In (b)(6) 2021, he had a femoral component that was shortened and in varus compared to his immediate post-op films, and an acetabular component that had migrated medially and proximally compared to immediate post-op films.The patient underwent a revision surgery on (b)(6) 2021 to address the issue.Both bhr components were explanted and replaced with a thr system from a competitor.The patient was transferred to the recovery room in stable condition.

Manufacturer Narrative

H3, h6: it was reported that a hip revision surgery was performed due to severe pain, discomfort, inflammation around the hip implants, and elevated blood metal ion levels, a femoral component that was shortened and in varus compared to his immediate post-op films, and an acetabular component that had migrated medially and proximally compared to immediate post-op films.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 cup and head concerned 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 for the head, and this failure will continue to be monitored.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, no prior applicable escalation actions were identified.The available medical documents were reviewed.Although elevated cobalt and chromium levels were reported, no lab values or lab reports were provided.As well, it was reported the femoral component was shortened and in varus and the acetabular component migrated medially and proximally compared to immediate post-op films; however, x-rays or x-ray reports were not provided.The intraoperative finding of the grossly loose femoral component can be seen as a result of the reported adverse tissue reaction, but changes in position or loosening could also accelerate wear and lead to an adverse tissue reaction.With the information provided, the clinical root cause of the reported events/ clinical reactions cannot be definitively confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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: ACETABULAR CUP HAP SIZE 52/58
• 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: 12471999
• MDR Text Key: 271451565
• Report Number: 3005975929-2021-00403
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2023
• Device Model Number: 74122158
• Device Catalogue Number: 74122158
• Device Lot Number: 18EW08091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male