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

Model Number	74122542
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Metal Related Pathology (4530)
Date of Event	03/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference: (b)(4).
Event or Problem Description
Bilateral patient.Plaintiff underwent medically-indicated two-stage revision of the bhr-tha left hip implants on (b)(6) 2018.(1st stage) and (b)(6) 2018 (2nd stage).On the first stage the stem, femoral head and sleeve were removed.At the second stage the zimmer components were removed along with the bhr-tha shell.The patient revision surgery was performed due to severe pain, limited mobility, metallosis, pseudotumor formation, and elevated cobalt and chromium ion levels.No s&n parts remained implanted.
Additional Manufacturer Narrative
It was reported that right hip revision surgery was performed.During the revision the stem, hemi head, modular sleeve and bhr cup were removed.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, dhr review, specific product labelling and ifu review and risk management review cannot be performed for the synergy stem, hemi head and modular sleeve.If this information becomes available at a later time, the task will be reopened and completed.A review of the complaint history for the bhr cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the bhr cup.This will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the bhr cup reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.It was also confirmed that all devices were sterilised through review of the dhr.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.No additional risks were identified as result of the reported event.Identified risks are reduced in severity / occurrence / detection as far as possible.The available medical documents were reviewed.For the bilateral two stage revisions; the clinical information provided, of the reported elevated metal ion levels, the pseudotumor, and the necrotic tissue 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 versus the reported infection.The cultures that positive for bacillus species on the left and mrse on the right were likely an hematogenous infection without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventive or corrective action has been initiated as a result of this investigation.
Additional Manufacturer Narrative
H10: additional information in b5 and h6 (health effect - clinical code and health effect - impact code were updated).

• 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: 10909147
• Report Number: 3005975929-2020-00462
• Device Sequence Number: 610692
• Product Code: KWL
• UDI-Device Identifier: 00885556070710
• UDI-Public: 00885556070710
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2022
• 2 Devices were Involved in the Event: 1 2

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?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 02/04/2021; 06/02/2022
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 02/08/2021; 06/02/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SLEEVE 74222100, LOT UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female