MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVLS MONO STEM 240MM SZ 16 HO; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	71354723
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after a thr surgery was performed, the patient experienced unspecified symptom due to failed greater trochanter fixation in previous surgery and subsequent stem subsidence.This adverse event was treated by a revision surgery on (b)(6) 2023, but it was cancelled due to the surgeon being unwell and unavailable to perform surgery on the day, so it was booked to (b)(6) 2023 in which the stem subsidence resulted in reduced leg length and an incision was made.In addition, the redapt slvls mono stem 240mm sz 16 ho was exchanged.Patient's current health status is unknown.
Additional Manufacturer Narrative
The reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the redapt sleeveless monolithic stem.Therefore, no investigation is deemed for the other devices.The device was not returned for evaluation; therefore, a device analysis could not be performed.The photographs were reviewed, and did not reveal any defects.The clinical/medical investigation concluded that, the reported stem subsidence, reduced leg length, and subsequent revision were related to the reported failed greater trochanter fixation (zimmer).The provided undated x-rays were reviewed.Previous images were not provided for comparison to review amount of subsidence, but the images provided are consistent as there is radiolucencies around the stem and within the greater trochanter consistent with subsidence.It cannot be concluded there was a mal performance of the smith and nephew implants.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that subsidence which has resulted in revision surgery and has occurred in conjunction with compaction grafting procedures usually may occur as a result of insufficient graft material, improper cement techniques, and/or varus stem alignment.This has been identified in adverse events in primary and revision surgery.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include procedural/user error, surgical complication, dislocation, dissociation, size selected and/or healing factors.Based on this investigation, the need for corrective action is not indicated.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 SLVLS MONO STEM 240MM SZ 16 HO
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-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: 17730495
• Report Number: 1020279-2023-01752
• Device Sequence Number: 6440424
• Product Code: LZO
• UDI-Device Identifier: 00885556579459
• UDI-Public: 00885556579459
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K211176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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: Health Professional
• Device Catalogue Number: 71354723
• Device Lot Number: 17GTM0053D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2017
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown