MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74122552
Medical Device Problem Codes	Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cyst(s) (1800); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Metal Related Pathology (4530)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a bhr tha surgery had been performed in the left hip on (b)(6) 2010, the patient experienced metallosis with both a pseudotumor and severe trunnionosis from metal-on-metal articulation.A revision surgery was performed on (b)(6) 2020 to treat the adverse event.The patient outcome is unknown.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed on the patients left hip.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.Without definitive part/lot numbers a complete complaint history review cannot be performed for the devices involved.As no device batch numbers were provided for investigation, a manufacturing record review, ifu review could not be performed.The risk management review have been performed for the alleged failure mode.If more information is received, this investigation will be reopened.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.
Additional Manufacturer Narrative
H3, h6: it was reported that left hip revision surgery was performed.During the revision, the cup, head, sleeve and stem were removed.As of today, the devices used in treatment have been requested but have not become available.A review of the historical complaints data for the cup, head, modular sleeve and stem was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product.No other similar complaints were identified for the cup or stem.Similar complaints were identified for the modular sleeve and head.However, as the devices are no longer sold, no action is to be taken.A search was also performed using part numbers, the reported failure modes and description summary to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.Other similar complaints were identified for the cup.This will continue to be monitored.No other similar complaints have been identified for the head, modular sleeve or stem.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.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 and no further actions are required at this time.A review of escalation actions related to the products and similar complaints 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.Smith and nephew has not received device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without additional information we cannot further investigate or confirm the reported complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.B5, g1, h6, h10.
Event or Problem Description
It was reported that a revision surgery was performed on the patients left hip due to failed left total hip arthoplastly secondary to metalosis from metal on metal articulation and trunnionosis, evidence of metalosis in the left hip with both a pseudotumor and severe trunnionosis.

• Brand Name: HEMI HEAD 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire ; UK
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire ; UK
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; spa park; austin, TX 78735 ; 5123913905
• MDR Report Key: 10440264
• Report Number: 3005975929-2020-00315
• Device Sequence Number: 4060192
• Product Code: NXT
• UDI-Device Identifier: 00885556071694
• UDI-Public: 885556071694
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/27/2014
• Device Catalogue Number: 74122552
• Device Lot Number: 09BW04043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 10/11/2020; 03/11/2022
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 10/14/2020; 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2009
• 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: 71309115/SYN POR PLUS HA HO STEM SZ 15.; 74222400/MODULAR SLEEVE +8MM 12/14.; CN: 74222400, LN: UNKNOWN.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male