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

Catalog Number	71354236
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery of her right tha system (unknown product) on (b)(6) 2020 due to (1) aseptic loosening of right total hip arthroplasty, status post revision for acetabular fracture and (2) delayed union of acetabular fracture, complicated.During the revision surgery, the acetabular section of the primary tha system was explanted and replaced with a redapt modular acetabular system, along with a smith and nephew acetabular augment and a competitor´s femoral head.As reported, the patient suffered from pain due to internal orthopedic prosthetic devices, implants and grafts.The patient underwent a revision surgery on (b)(6) 2023 to address the issues.During this second revision surgery, the acetabular augment, shell, and liner were explanted.There is no further information at this time.The current state of health of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (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.

• Brand Name: REDAPT FULLY POROUS SHELL 62MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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: 20233629
• Report Number: 1020279-2024-01855
• Device Sequence Number: 8754839
• Product Code: KWZ
• UDI-Device Identifier: 00885556321546
• UDI-Public: 885556321546
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2024

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
• Device Catalogue Number: 71354236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/16/2024
• 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: PN: 71332520 / LOT: UNKNOWN; PN: 71332525 / LOT: UNKNOWN; PN: 71332530 / LOT: UNKNOWN.; PN: 71354439 / LOT: UNKNOWN; PN: 71354503 / LOT: UNKNOWN; PN: 75018956 / LOT: UNKNOWN; PN: 75100454 / LOT: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 95 KG