MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVD MONO STEM 240MM SZ 15 HO; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	71354822
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a revision surgery had been performed on (b)(6) 2022, the patient experienced pain and shortening.A revision surgery was booked on (b)(6) 2022 to address this event.The acetabular components, from zimmer, were retained, while the femoral components (redapt stem and sleeve and an oxinium head) were removed.A spectron revision stem was inserted in exchange.The patient is recovering.
Additional Manufacturer Narrative
D11: concomitant medical products and therapy dates.Section h3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the x-ray photos provided demonstrates the persistent intertrochanteric fracture and broken cerclage wire.The patient impact beyond the reported pain and revision could not be determined but the presence of the fracture is the likely root cause of the additional revision.No further clinical/medical assessment can be rendered at this time.Should any additional clinical information be provided, this complaint will be re-evaluated.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers 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 the patient should be advised to report any pain and unusual incidences.Position changes in the components may compromise the durability of the implants, this has been identified as warnings and precautions.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 these products and event.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition, procedural/user error, surgical complication, size selected, healing factors or postoperative care.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.B5: describe event or problem.
Event or Problem Description
It was reported that a revision surgery had been performed on (b)(6) 2020 due to a peri-prosthetic fracture.Implants that are not from s+n were explanted and replaced with s+n implants.After the revision performed on (b)(6) 2020, the patient experienced pain and shortening.Another revision surgery was booked on (b)(6) 2022 to address this event.In this revision surgery, conducted on (b)(6) 2022, the s+n redapt stem, sleeve, and an oxinium femoral head were explanted.The patient is recovering.

• Brand Name: REDAPT SLVD MONO STEM 240MM SZ 15 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: 15956511
• Report Number: 1020279-2022-04934
• Device Sequence Number: 4938501
• Product Code: LZO
• UDI-Device Identifier: 00885556580097
• UDI-Public: 00885556580097
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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 Model Number: 71354822
• Device Catalogue Number: 71354822
• Device Lot Number: 17ETM0083C
• 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: 11/17/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 12/11/2022
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2017
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OXINIUM FEM HD 12/14 36 MM M/+4, LOT#:20GM10620; REDAPT MOD SLV, LOT#:16JM19065A
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown