MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVLS MONO REV STEM 300MM SZ15 SO; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	71354739
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent an elective rtha revision.The patient suffered a distal fracture ((b)(6)), trochanter fracture fragments ((b)(6) 2017), and fracture of the middiaphysis of right femur ((b)(6) 2017).The hip has dislocated twice (b)(6).The stem continues to subside.The patient also developed an infection.
Additional Manufacturer Narrative
Information indicates that part 71302800/16km09726 was not implanted, but was wasted during the surgery.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Our clinical investigation noted that based on reports from the surgeon, the trochanter fracture fragments throughout the extremity are likely the reason for the ongoing pain, decreased mobility with the likelihood of future repeated dislocations.No further clinical/medical investigation is warranted at this time.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed part revealed no additional complaints for this failure mode with the same batch number.Products were sterilized according to sterilization release documentation from quality control.Without the return of the actual product involved, our investigation of this report is inconclusive.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.A clinical evaluation was conducted and confirms the intra operative fluoroscopic image was provided but little can be concluded from this image.An x-ray showed a dislocation of prosthetic hip joint from socket.Without the implantation report, the root cause of the periprosthetic fracture cannot be determined.The intra-operative wound culture did confirm a pseudomonas however, there is no evidence this was caused by the smith and nephew device.We cannot rule out the intra-operative wound findings of possible infection and other conditions such a aseptic necrosis of head of humerus, epilepsy with impairment of consciousness, seizures, osteoporosis, a right hip replacement, non-compliance, the daughter¿s interference with medical treatment, the patient¿s age, decreased mobility and fall history cannot be excluded as factors contributing to the dislocations and revisions.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.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 of this event could include poor bone quality or a traumatic injury.

• Brand Name: REDAPT SLVLS MONO REV STEM 300MM SZ15 SO
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7059795
• Report Number: 1020279-2017-01124
• Device Sequence Number: 19171849
• Product Code: LZO
• UDI-Device Identifier: 00885556579602
• UDI-Public: 00885556579602
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/20/2020

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 Expiration Date: 09/14/2026
• Device Model Number: 71354739
• Device Catalogue Number: 71354739
• Device Lot Number: 16HTM0017J
• Initial Date Received by Manufacturer: 11/05/2017
• Supplement Date Received by Manufacturer: 11/05/2017; 11/05/2017; 04/10/2020
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 11/28/2017; 04/06/2018; 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71302800/16KM09726; 71302808/16JM17391; UNKNOWN LINER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR