MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT MODULAR SHELL 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71352360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Fluid Discharge (2686); Swelling/ Edema (4577)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that fluid collection and revision surgery was performed due to unspecified reasons.The outcome of the patient in resolved.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that fluid collection and revision surgery was performed on the right hip due to continued accumulation of fluid.The devices were not explanted.The outcome of the patient is resolved.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the crf did not provide any clinical insight into the reported issue of ¿continued accumulation of fluid.¿ it has been reported that the event was treated with a tha revision and was resolved.Without the operative reports, a thorough medical assessment cannot be performed.Should any additional relevant clinical information be provided, this complaint would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to traumatic injury, joint tightness, material in use or patient reaction.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: REDAPT MODULAR SHELL 60MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11744308
• Report Number: 1020279-2021-03696
• Device Sequence Number: 19859111
• Product Code: MBL
• UDI-Device Identifier: 00885556657867
• UDI-Public: 00885556657867
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K182109
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2021

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: 71352360
• Device Catalogue Number: 71352360
• Device Lot Number: 20DM10962
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 04/08/2021; 10/06/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 05/13/2021; 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71342804/OXINIUM FEM HD 12/14 28MM +4; 71358207/OR3O DUAL MOBILITY LINER 46/60; 71358221/OR3O DM XLPE INSERT 28/46
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 107