MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 40/46; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122146

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Metal Related Pathology (4530)

Event Date 01/08/2018

Event Type  Injury  

Manufacturer Narrative

Complaint reference: (b)(4).

Event Description

Bilateral patient.Plaintiff underwent medically-indicated two-stage revision on (b)(6) 2019 (2nd stage).On the during the second stage the zimmer stem was removed again along with the bhr-tha shell, head and sleeve.The patient revision surgery was performed due to severe pain, limited mobility, metallosis, pseudotumor formation, and elevated cobalt and chromium ion levels.No s&n parts remained implanted.

Manufacturer Narrative

H3, h6: it was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr cup, hemi head, modular sleeve and synergy stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the stem.Similar complaints have been identified for the stem, this will continue to be monitored.Similar complaints have been identified for the cup and head.However, as the devices are 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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.All the released devices involved met manufacturing specifications at the time of production.It was also confirmed that all devices were sterilised.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 available medical documents were reviewed.The root cause of the first three revisions from the multiple dislocations cannot be concluded.It is unknown what impact the reported infection, the scar tissue and the it band, (on the left atrophied, and a hole in it on the right), had on the dislocations.For the bilateral two stage revisions; the clinical information provided, of the reported elevated metal ion levels, the pseudotumor, and the necrotic tissue 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 the implant failure versus the reported infection.The cultures that tested positive for bacillus species on the left and mrse on the right were likely an hematogenous infection.The impact to the patient was long term pain with multiple surgeries and recoveries to go through.Without return of the actual devices or further information we cannot further investigate the details supplied in this complaint, our investigation remains inconclusive and a definitive root cause cannot be determined.Based on the information provided we are unable to speculate on specific factors known to contribute to the alleged fault.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Event Description

Bilateral patient.Plaintiff underwent medically-indicated two-stage revision of the bhr-tha left hip implants on (b)(6) 2018.(1st stage) and (b)(6) 2019 (2nd stage).In the first stage, the stem was removed and replace with a zimmer one.A functional antibiotic spacer was also placed.In the second stage, the zimmer stem was removed again along with the bhr-tha shell, head and sleeve.The patient¿s two (2) stage revision surgery was performed due to suspected bacillus hip infection, elevated metal ion levels and metallosis with adverse local tissue reaction, severe pain, limited mobility, and pseudotumor formation.No s&n parts remained implanted.

• Brand Name: ACETABULAR CUP HAP SIZE 40/46
• 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: 10908773
• MDR Text Key: 218499399
• Report Number: 3005975929-2020-00460
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010565792
• UDI-Public: 03596010565792
• 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: Other,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2012
• Device Model Number: 74122146
• Device Catalogue Number: 74122146
• Device Lot Number: 07HW12942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2007
• 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
• Treatment: 74222200, LOT NUMBER: 08GW17835
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female