MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT MODULAR SHELL 62MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71352362
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	09/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: date of event (b3).
Additional Manufacturer Narrative
H10: internal reference number: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication identified through the review of clinical evidence from post market clinical data collection activities that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that the patient underwent a revision surgery of his left tha system (unknown manufacturer) on (b)(6) 2019 due to subsidence of left femoral stem.During the revision surgery, all the system was explanted and replaced with a new system composed by a smith and nephew redapt modular shell, and a redapt femoral component.As reported, on (b)(6) 2019, the patient suffered from fluid build up and left lower extremity swelling.It is unknown how this adverse event was treated, but it did result in readmission of the patient to the hc facility.There is no further information at this time.The current state of health of the patient is unknown.

• Brand Name: REDAPT MODULAR SHELL 62MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20196561
• Report Number: 1020279-2024-01809
• Device Sequence Number: 7584017
• Product Code: MBL
• UDI-Device Identifier: 00885556657874
• UDI-Public: 885556657874
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182109
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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: Lay User/Patient
• Device Catalogue Number: 71352362
• Device Lot Number: UNKNOWN
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 71338690 / R3 20 DEG XLPE LNR 40MM ID X 620D; 71354486 / REDAPT SLVLS MONO STEM 190MM SZ 19 HO
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 143 KG