MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 50MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 74122550

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

Patient Problems Osteolysis (2377); Metal Related Pathology (4530)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after left bhr tha construct was implanted on (b)(6) 2010, the plaintiff experienced metallosis.A revision surgery was performed on (b)(6) 2020 to treat this adverse event.During the surgery, significant osteolysis was noted around the cup, as well as large collection of brown fluid.Plaintiff outcome is unknown.

Manufacturer Narrative

Section h6 were corrected.

Manufacturer Narrative

H3, h6: it was reported that a left hip revision surgery was performed.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 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.Other similar complaints were identified to involve this batch for the acetabular cup and this failure will continue to be monitored.Other similar complaints were identified to involve this batch for the hemi head and 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 the hemi head and this failure will continue to be monitored for the acetabular cup, and for the hemi head no action is to be taken as they are no longer sold.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.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.A risk management review was performed for the acetabular cup.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.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 for the hemi head and sleeve and confirmed to reduce associated risks as far as possible.No further escalation actions required.No prior applicable escalation actions were identified for the acetabular cup.The available medical documents were reviewed.The clinical information provided of significant osteolysis, large collections of brown fluid, and limited fixation proximally of the femoral stem 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.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.

• Brand Name: HEMI HEAD 50MM
• 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: 13101087
• MDR Text Key: 286147587
• Report Number: 3005975929-2021-00590
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00885556071205
• UDI-Public: 885556071205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062408
• 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
• Report Date: 05/03/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2013
• Device Catalogue Number: 74122550
• Device Lot Number: 08MW20674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 04/21/2022; 04/29/2022
• Supplement Dates FDA Received: 05/03/2022; 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2008
• 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: 74222200/MODULAR SLEEVE {} PLUS 0MM 12/14.
• Patient Age: 61 YR
• Patient Sex: Male