MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 42MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number	74122542
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Necrosis (1971); Metal Related Pathology (4530)
Date of Event	07/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a right bhr on (b)(6) 2008 due to arthritis.Plaintiff implants failed and presented a pseudotumor.Plaintiff underwent right revision surgery on (b)(6) 2020 where compromise and necrosis of the posterior third of the g.Medius and complete necrosis of the g.Minimus were noted.The pseudotumor was within the joint and around the greater trochanteric bursa which was debrided.There was some metallosis in the soft tissues of the posterior joint capsule.The patient's condition is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that a right bhr revision surgery was performed due to pseudotumor.Necrosis and metallosis in the soft tissues were found intraoperatively.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the devices concerned.A review of historical complaints data was performed using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints were identified for the hemi head, no similar complaints were identified for the modular sleeve.However, as the devices are no longer sold, no action is to be taken.As no device batch numbers were provided for investigation, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.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 reported necrosis and pseudotumor are consistent with the metallosis noted intraoperatively; however, with the information provided the clinical root cause of the reported metallosis cannot be confirmed.It should be noted however, the retroversion of the native acetabulum and uncoverage superolaterally as well as posteriorly, superiorly due to the retroversion cannot be ruled out as contributing factors to the necrosis, pseudotumor, and metallosis.It cannot be concluded the reported events/ clinical reactions were associated with a malperformance of the implant.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 42MM
• 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: 14973820
• Report Number: 3005975929-2022-00417
• Device Sequence Number: 20108512
• Product Code: KWL
• UDI-Device Identifier: 00885556070710
• UDI-Public: 00885556070710
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K062408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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 Model Number: 74122542
• Device Catalogue Number: 74122542
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 07/10/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2745-2015
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74222200/MODULAR SLEEVE {} PLUS 0MM 12/14; UNKN ANTHOLOGY HIP IMPL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown