MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD 50/28MM BH DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	74121650
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, after a thr, a oxnm fem hd 28 mm +12 disassociated from a 50/28 mm bh dual mobility insert.Patient walked on it for some time before seeking medical attention.Cup was revised and a new femoral head implanted.Echelon stem was well fixed and remained.Surgery was performed, without any delay, with a competitor back-up device instead.No other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Additional information: d4 (expiration date), h4 (manufacturing date), h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: it was reported that a hip revision surgery was performed due to disassociation between the insert and the femoral head.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 devices concerned was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the insert.No other similar complaints have been identified for the femoral head.This will continue to be monitored.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.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient's current condition is unknown.The patient impact could not be determined based on the limited information provided.Should any additional clinical information be provided, this complaint will be re-evaluated.Based on the information provided we cannot confirm or further investigate the reported 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, excessive patient weight, trauma to the joint replacement, malpositioning of the implants, or muscle or fibrous tissue laxity.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: 50/28MM BH DUAL MOBILITY INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 15407853
• Report Number: 3005975929-2022-00470
• Device Sequence Number: 6744631
• Product Code: LPH
• UDI-Device Identifier: 00885556577240
• UDI-Public: 00885556577240
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K171934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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 Model Number: 74121650
• Device Catalogue Number: 74121650
• Device Lot Number: B2000463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2020
• 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: OXNM FEM HD 28 MM +12, LOT#: 19FM08742
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown