MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF CNSTR LNR ADPTR 50-52OD E; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	71323144
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a thr performed on (b)(6) 2021, it was reported that a patient experimented a dislocation of the implant.A revision surgery took place on (b)(6) 2021 to evaluate the best way to fix the problem and the acetabular cup and liner were replaced with another company's implants.New smith and nephew femoral head implanted.It is unknown how femoral head was able to dislocate out of constrained liner.Patient condition is unknown.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting.The information states that this device is a concomitant reported in mdr (b)(4) therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: REF CNSTR LNR ADPTR 50-52OD E
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12285372
• Report Number: 1020279-2021-06178
• Device Sequence Number: 11716769
• Product Code: KWZ
• UDI-Device Identifier: 03596010482648
• UDI-Public: 03596010482648
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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: 71323144
• Device Catalogue Number: 71323144
• Device Lot Number: 18JM15953
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 09/03/2021
• 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