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

Catalog Number	71352360
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a right hip revision surgery on (b)(6) 2020 in which smith & nephew were implanted; patient sustained an unspecified mechanical complication of internal right hip prosthesis that required readmission on (b)(6) 2020.Current patient's health status is unknown.No other complications were reported.
Additional Manufacturer Narrative
Internal reference number: (b)(4).H10: 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.
Additional Manufacturer Narrative
Additional information: h6 (type of investigation), h10 (roi).H3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The devices' batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.For the modular shell and stem, a review of complaint history of the previous 12 months revealed a single similar event for the listed devices and, for the femoral head, dual mobility liner and insert, the review revealed multiple similar events.However, these similar events reported the same harm but no sufficient information about the failure mode was provided, so these events could not be associated with the reported event.A review of the instructions for use documents for total hip systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.An evaluation of the risk management files and prior actions could not be performed because there is not enough information about device failure mode or patient adverse event in order to perform the retrospective review.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.No details of the alleged fault, malfunction or injury were provided, therefore no factors that can contribute can be delineated.Based on this investigation, the need for corrective action is not indicated.Should 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
• 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: 19553278
• Report Number: 1020279-2024-01169
• Device Sequence Number: 6711547
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71352360
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 08/07/2024
• 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: 71342804/OXINIUM FEM HD 12/14 28MM +4; 71354724/REDAPT SLVLS MONO STEM 240MM SZ 17 HO; 71358207/OR3O DUAL MOBILITY LINER 46/60; 71358221/OR3O DM XLPE INSERT 28/46
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Unknown