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 Pain (1994); Metal Related Pathology (4530)

Event Date 04/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, after a bhr tha on (b)(6) 2009 due to degenerative arthritis, plaintiff has experience pain and was diagnosed with gluteus minimums tendon tear.A revision surgery was performed on (b)(6) 2021 when it was found some metallic staining on the morse taper and on the femoral head therefore the hemi head 46mm was explanted.Patient outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that a hip revision surgery was performed.The hemi head 46mm was explanted.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the historical complaints data for the acetabular cup, hemi head and sleeve 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 prior 12 months as of the complaint aware date.No other similar complaints were identified to involve this batch for the acetabular cup and hemi head.Other similar complaints were identified to involve this batch for the sleeve.However, as the device is no longer sold, no action is to be taken.No other similar complaint has been identified for the part number and the reported failure mode for the sleeve.Other similar complaints have been identified for the part number and the reported failure mode for the acetabular cup and hemi head.However, as bhr systems of this size, hemi heads, sleeves are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known 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 upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.The =46mm bhr resurfacing system, hemi heads, sleeves have been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.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 required.The available medical documents were reviewed.The clinical information provided, of the (abundant slightly white fluid, gluteus minimus tear, metallic staining, black staining on the morse taper and femoral head.Mild gray staining, pseudocapsule, black debris) 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.Without the return of the devices used in treatment or additional information we cannot advance the investigation or confirm this 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, excessive patient weight, trauma to the joint replacement.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: 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: 12871021
• MDR Text Key: 281223882
• Report Number: 3005975929-2021-00539
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2013
• Device Catalogue Number: 74122546
• Device Lot Number: 08GW18088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2008
• 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: 71306109/SYN POR HO FEM COM SZ 9; 74222100/MODULAR SLEEVE -4MM 12/14
• Patient Age: 76 YR
• Patient Sex: Female