MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD 46/28MM BH DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	74121646
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Us legal mdl.It was reported that after revision surgery where s+n devices were implanted, and hip was revised to a tha; plaintiff suffer a hip dislocation.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.Details about the surgery including the explanted and implanted devices are unknown.Plaintiff outcome is unknown.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that 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 bh dual mobility insert 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 and for the part number and the reported failure mode.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.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, no prior applicable escalation actions were identified.The available medical documents were reviewed.Without the supporting clinical/ medical records including imaging, operative report and/or return of the explanted device, the root cause of the dislocation and subsequent revision cannot be confirmed.The patient impact beyond the dislocation, revision, and expected transient post-op convalescence period cannot be determined.Without the return of the devices used in treatment or additional information we cannot advance the investigation or confirm this complaint; 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.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: 46/28MM BH DUAL MOBILITY INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 12779309
• Report Number: 9613369-2021-00397
• Device Sequence Number: 5749522
• Product Code: JDI
• UDI-Device Identifier: 00885556577226
• UDI-Public: 00885556577226
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2022

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: 06/13/2025
• Device Model Number: 74121646
• Device Catalogue Number: 74121646
• Device Lot Number: B1811156
• 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: 10/18/2021
• Supplement Date Received by Manufacturer: 10/18/2021; 03/10/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 11/09/2021; 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female