MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 74122546

Device Problem Biocompatibility (2886)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Hip Fracture (2349); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 02/26/2020

Event Type  Injury  

Event Description

*us legal mdl* it was reported that, after a bhr tha construct had been implanted on (b)(6) 2009, the plaintiff experienced pain, a fracture on the greater trochanter, osteolysis with very high cobalt levels in blood and trunnions.A revision surgery was performed on (b)(6) 2020 to treat these adverse events.During the surgery, a drab olive-colored fluid egressed from the joint.A sample was evaluated, indicating the presence of an infection.Corrosion was found in the union between the femoral head and the sleeve, as well as on the stem trunnion.Even though osteolysis was found around the femoral and acetabular regions, the cup and the stem were determined to be well fixed, and were not explanted.The modular femoral head was the only device replaced with an oxinium head with a poly liner to construct a dual mobility construct.The patient outcome is unknown.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the head and sleeve were removed.The stem and cup remained implanted.As of today, the implanted devices, all of which were used in treatment and additional information have been requested for this complaint but have not become available.A review of the complaint history for the head and modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.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 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 revision operative report did not note findings consistent with the reported ¿older greater trochanteric fracture.¿ the reported elevated metal ions (values, units, and reference range not provided) and intraoperative findings of olive drab colored fluid, paste-like material, trunnionosis, osteolysis and bone loss may be consistent with a reaction to metal debris or corrosion from trunnionosis.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 malperformance of the implant or implant failure.The impact to the patient beyond the revision and expected post-op convalescent period cannot be determined.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.Due to insufficient information provided we are unable to determine 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.

Manufacturer Narrative

H3, h6: it was reported that left hip revision surgery was performed due to pain, fracture on the greater trochanter, osteolysis with very high cobalt levels in blood and trunnions.A drab olive-colored fluid egressed from the joint was observed intraoperatively.During the revision, the head and sleeve were removed.The stem and cup remained implanted.As of today, the implanted devices, all of which were used in treatment and additional information have been requested for this complaint but have not become available.A review of the historical complaints data for the devices 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 hemi head and modular sleeve.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.All released devices involved met manufacturing specifications upon release for distribution.The review of the products 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, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.The revision operative report did not note findings consistent with the reported ¿older greater trochanteric fracture.¿ the reported elevated metal ions, intraoperative findings of olive drab colored fluid, paste-like material, trunnionosis, osteolysis and bone loss, as well as the pathological findings may be consistent with a reaction to metal debris or corrosion from trunnionosis.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 malperformance of the implant or implant failure.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.

Event Description

It was reported that, after a left bhr tha construct had been implanted on (b)(6) 2009, the plaintiff experienced pain, a fracture on the greater trochanter, osteolysis with very high cobalt levels in blood and trunnions.A revision surgery was performed on (b)(6) 2020 to treat these adverse events.During the surgery, a drab olive-colored fluid egressed from the joint.A sample was evaluated, indicating the presence of an infection.Corrosion was found in the union between the femoral head and the sleeve, as well as on the stem trunnion.Even though osteolysis was found around the femoral and acetabular regions, the cup and the stem were determined to be well fixed and were not explanted.The modular femoral head and the modular sleeve were replaced with an oxinium head with a poly liner to construct a dual mobility construct.The patient outcome is unknown.

• Brand Name: HEMI HEAD 46MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• 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: 11898181
• MDR Text Key: 254272157
• Report Number: 3005975929-2021-00288
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00885556071588
• UDI-Public: 885556071588
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/23/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2013
• Device Catalogue Number: 74122546
• Device Lot Number: 08JW18832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 09/02/2021; 10/25/2022; 11/15/2022
• Supplement Dates FDA Received: 09/04/2021; 11/02/2022; 11/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: PN:74222200 , LN: 08FW17516
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male