MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD 54/28MM BH DUAL MOBILITY INSERT; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/POLYMER,POROUSUNCEMENTED

Model Number	74121654
Medical Device Problem Codes	Unintended Movement (3026); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a closed reduction due to dislocation on (b)(6) 2019.The cup was retained and the unknown ceramic head was involved.The stem was from a competitor device.
Additional Manufacturer Narrative
It was reported that the patient underwent a closed reduction due to dislocation.The implanted devices, were all used in treatment.Additional information have been requested for this complaint but have not become available.No lot numbers were provided; hence documentation review could not be completed.If more information is received, this investigation will be reopened.Without the details of the devices involved in this complaint, a specific risk management review for the devices cannot be performed.If this information becomes available at a later time, the task will be reopened and completed.The available medical documents were reviewed.The manual manipulation of the hip as well as the hip instability due to his previous anterior and posterior operative approaches cannot be ruled out as contributing factors to his acute dislocation.The dislocation is not associated with a malperformance of the implant.The patient impact beyond the closed reduction cannot be determined.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 preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: 54/28MM BH DUAL MOBILITY INSERT
• Common Device Name: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/POLYMER,POROUSUNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 10269948
• Report Number: 3005975929-2020-00248
• Device Sequence Number: 811697
• Product Code: LPH
• UDI-Device Identifier: 00885556577264
• UDI-Public: 00885556577264
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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: 74121654
• Device Catalogue Number: 74121654
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention