MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD44MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number	74122544
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference number: case (b)(4).
Event or Problem Description
It was reported that after a right r3-tha construct was implanted on (b)(6) 2009, plaintiff experienced severe pain, limited mobility, metallosis, and elevated cobalt and chromium levels.A revision surgery was performed on (b)(6) 2021 to treat these adverse events.During the surgery, the femoral head and liner were replaced.The patient was taken to the recovery room in stable condition.¿.
Additional Manufacturer Narrative
H3, h6.It was reported that a right 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 hemi head, modular sleeve and r3 liner 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 hemi head and r3 liner.Other similar complaints were identified to involve this batch for the modular sleeve.However, as the device is no longer sold, no action is to be taken.Other similar complaints have been identified for the part number and the reported failure mode for the hemi head and r3 liner.No other similar complaints have been identified for the part number and the reported failure mode for the modular sleeve.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.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.Hemi heads, sleeves, r3 liners 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.Although severe pain, limited mobility, metallosis, and elevated cobalt and chromium levels were reported, no laboratory values or laboratory reports were provided, and the revision operative report did not note findings of metallosis.With the information provided the clinical root cause of the reported severe pain, limited mobility, and elevated cobalt and chromium cannot be confirmed, and it cannot be concluded the reported events/ clinical reactions were associated with a mal performance of the implant.Based on the available information we cannot 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.Internal reference number: (b)(4).

• Brand Name: HEMI HEAD44MM
• Common Device Name: 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: 12782902
• Report Number: 3005975929-2021-00517
• Device Sequence Number: 3607775
• Product Code: KWL
• UDI-Device Identifier: 00885556070994
• UDI-Public: 00885556070994
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K062408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2012
• Device Model Number: 74122544
• Device Catalogue Number: 74122544
• Device Lot Number: 07HW13129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: R3 44MM ID US COCR LNR 56MM.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male