MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVLS MONO STEM 190MM SZ 16 SO; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	71354465
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Arthralgia (2355); Thrombosis/Thrombus (4440); Osteomyelitis (4533)
Date of Event	06/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, as part of an unspecified medical indication, a patient underwent a thr revision surgery on the left hip on (b)(6) 2016.During this procedure, a redapt slvls mono stem 190mm sz 16 so was implanted.In the first follow up (3 weeks postop), a trochanteric fracture was found.It is unknown if the trochanteric fracture intraoperatively or after the procedure.It is unknown if/how the adverse event was treated.4 months postoperatively, the patient reported stiffness and pain.Additional details about the implanted prosthesis before the first revision surgery was performed are not available.After this adverse event the patient suffered from an osteomyelitis and a dvt.As the data collection has been done retrospectively and is anonymized, further details on the patient's final outcome are unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the data obtained in this study was retrospective and is anonymized.Consequently, smith and nephew has not received the device/adequate clinical documentation to fully evaluate the complaint.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional medical information be provided, this complaint would be re-assessed.A review of complaint history did not reveal additional complaints for the listed device for the same failure mode.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant and surgical technique.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.
Event or Problem Description
It was reported that, as part of an unspecified medical indication, a patient underwent a thr revision surgery on the left hip on (b)(6) 2016.During this procedure, a redapt slvls mono stem 190mm sz 16 so was implanted.In the first follow up (3 weeks postop), a trochanteric fracture was found.It is unknown if the trochanteric fracture intraoperatively or after the procedure.It is unknown if/how the adverse event was treated.4 months postoperatively, the patient reported stiffness and pain.Additional details about the implanted prosthesis before the first revision surgery was performed are not available.After this adverse event the patient suffered from an osteomyelitis (covered under (b)(4)) and a dvt (covered under ((b)(4)).As the data collection has been done retrospectively and is anonymized, further details on the patient's final outcome are unknown.

• Brand Name: REDAPT SLVLS MONO STEM 190MM SZ 16 SO
• 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
• MDR Report Key: 12529547
• Report Number: 1020279-2021-07139
• Device Sequence Number: 19078434
• Product Code: LZO
• UDI-Device Identifier: 00885556580592
• UDI-Public: 00885556580592
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 71354465
• Device Catalogue Number: 71354465
• Device Lot Number: UNKN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 56 YR