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 Problem Biocompatibility (2886)

Patient Problems Pain (1994); Osteopenia/ Osteoporosis (2651); Tissue Breakdown (2681); Metal Related Pathology (4530); Implant Pain (4561)

Event Date 10/18/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

Us legal mdl: it was reported that, after right hip bhr surgery was performed on (b)(6) 2015, the patient experienced persistent pain, elevated cobalt and chromium levels, and tissue corrosion.This adverse event was treated with a revision surgery on (b)(6) 2021.During the revision surgery, an abundant amount of tissue reaction to the metal debris with discoloration was found, as well as femoral bone loss.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: it was reported that revision surgery was performed on the patients right hip.As of today the devices used in treatment have been requested but have 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, device labelling and ifu review could not be performed.A risk management review was performed for the bhr head and cup.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 prior escalation actions could not be completed due to insufficient information.The available medical information was reviewed.Based on the reported symptoms it cannot be concluded that the events/clinical reactions of persistent pain, elevated cobalt and chromium levels, and tissue corrosion were associated with a mal-performance of the implant.Without additional information we cannot further investigate or confirm the reported 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 this investigation, the need for corrective or preventative action is not indicated.

Manufacturer Narrative

Section h3, h6: it was reported that right hip revision surgery was performed due to persistent pain, elevated cobalt and chromium levels and tissue corrosion.The devices, which were used in treatment.Were not returned for evaluation.A review of the historical complaints data for the bhr head and bhr 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 of 12 months prior to the date in which the complaint was reopened.No other similar complaints were identified to involve either batch.Other similar complaints have been identified for the part number and the reported failure mode in this timeframe for the head and cup, and this failure will continue to be monitored through routine monthly trending.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes a risk management review was performed.No additional risks were identified as result of the reported event.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 quality escalations was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.The intraoperative finding of loosening of the femoral component can be seen as a result of metallosis, but changes in position or loosening could also accelerate wear and lead to metal debris and result in metallosis.The reported pain and elevated metal ion levels, and abundant amount of tissue reaction (discoloration of green and brown) may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are 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 we cannot further investigate the complaint, 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.If the products or additional information become available in the future, this case will be reopened.Based on this investigation the need for corrective and preventative action is not indicated.H6: health effect - clinical code and health effect - impact code.

Event Description

It was reported that, after undergoing right hip bhr resurfacing surgery due to osteoarthritis on (b)(6) 2015, the patient experienced persistent pain, elevated cobalt and chromium levels and tissue corrosion.These complications were treated by performing a revision surgery on (b)(6) 2021, in which an abundant amount of tissue reaction to the metal debris with discoloration was found, as well as femoral bone loss.In addition, the femoral component was noted to be loose.Both bhr cup and head were explanted, and a competitor¿s tha system was placed in exchange (stryker).Patient¿s current health status is unknown.

Manufacturer Narrative

H10 ¿ additional information.A2- age at the time of event.A4- patient weight.B5- describe event or problem.B6- relevant tests.B7- other relevant history.D4 - catalog number, lot number, expiration date, unique identifier (udi) #.G4 - pma/510(k)number.H4 - device manufacture date h11 ¿ corrected data.B2- outcomes attributed to adverse event.B5- describe event or problem.D1- brand name.E1- initial reporter name and address.G2- report source.H6- evaluation codes.

• 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: 13975491
• MDR Text Key: 288358524
• Report Number: 3005975929-2022-00094
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: 74122158
• Device Catalogue Number: 74122158
• Device Lot Number: 15CW04453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• 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): Required Intervention; Other; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 102 KG