MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVLS MONO STEM 240MM SZ 15 SO; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number	71354704
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Unequal Limb Length (4534)
Date of Event	10/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that, after a thr surgery performed on (b)(6) 2021, a patient experienced a first revision surgery due to for impingement, subsidence of polarstem on (b)(6) 2021 where a redapt 240mm sleeveless revision stem size 15 standard offset and an oxinium femoral head 12/14 taper 36 mm +0 were implanted.Then, on (b)(6) 2021, the patient underwent a second revision surgery due to loosening and leg length discrepancy, so the redapt 240mm sleeveless revision stem size 15 standard offset and the oxinium femoral head 12/14 taper 36 mm +0 were explanted and replaced with a cpcs stem.In the work up, the surgeon commented that he had under reamed/sized the redapt stem, hence it subsiding, so the is no fault placed on the device.Current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, reportedly, the root cause of the second revision surgery was due to subsidence of redapt sleeveless stem (>2cm), loosening and leg length discrepancy.The clinical root cause of the loosening and leg length discrepancy cannot be definitively concluded, however, ¿the surgeon commented that he had under reamed/sized the redapt stem, hence it subsiding, so the is no fault placed on the device¿ and the user technique is most likely a contributing factor.The patient impact was loosening, stem subsidence, leg length discrepancy, and the revision.Further patient impact cannot be determined, and the patient¿s current health status is unknown.Therefore, no further clinical medical assessment can be rendered at this time.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 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 risk management file and instructions for use documents 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 product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural/user error, surgical complication or patient medical history.The contribution of the device to the reported event could not be corroborated.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 SLVLS MONO STEM 240MM SZ 15 SO
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: 12707302
• Report Number: 1020279-2021-07696
• Device Sequence Number: 4498779
• Product Code: MEH
• UDI-Device Identifier: 00885556579299
• UDI-Public: 00885556579299
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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 Model Number: 71354704
• Device Catalogue Number: 71354704
• Device Lot Number: 20DTM0035B
• 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: 10/07/2021
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 74 YR
• Patient Sex: Female