MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 56MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	74122556
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Metal Related Pathology (4530)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
Usa legal - it was reported that the patient underwent a revision surgery of the right hip on (b)(6) 2021 due to trunnionosis, inflammatory and adverse local soft tissue reaction associated with metal-on-metal bearing of hip replacement prothesis an right greater trochanteric displaced fracture (pathologic type-related to osteolysis).The primary right bhr tha surgery was performed on (b)(6) 2009.The patient current health status is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that right hip revision surgery was performed.During the revision, the hemi head and the modular sleeve were explanted.The acetabular cup remained implanted.As of today, the implanted devices, all of which were used in treatment and explanted during the revision surgery have not been returned for evaluation.A review of the historical complaints data for the acetabular cup, hemi head and modular 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 hemi head.Other similar complaints were identified to involve this batch for the acetabular cup and the modular sleeve, and this failure will continue to be monitored for the acetabular cup.The modular sleeve is no longer sold, no action is to be taken.No other similar complaints have been identified for the part number and the reported failure mode for the acetabular cup, hemi head and modular sleeve.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 manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.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 for the acetabular cup.Hemi heads, modular 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, the listed batches were manufactured before corrective action implementation.No further escalation actions required.The available medical documents were reviewed.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (trunnionosis, inflammation, adverse local soft tissue reaction and greater trochanteric displaced fracture) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.Based on the available information we can confirm the reported complaint, however without the return of the devices used in treatment and 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, 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 56MM
• 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: 13423154
• Report Number: 3005975929-2022-00034
• Device Sequence Number: 5328034
• Product Code: KWL
• UDI-Device Identifier: 00885556071939
• UDI-Public: 885556071939
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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: 08/29/2012
• Device Catalogue Number: 74122556
• Device Lot Number: 07HW13149
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/11/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male