MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR HO FEM COM SZ 13; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71306113
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Bilateral patient.It was reported that, following an initial left r3-tha on (b)(6) 2010, plaintiff experienced left hip pain and popping episodes.Plaintiff underwent revision surgery on (b)(6) 2018, where the acetabulum was noted to be loose with erosion and broken screw heads.Metallosis, debris and fluid were observed.The femoral stem was retained.(cover under (b)(4)) on (b)(6) 2022, plaintiff experienced left hip pain and x-rays showed hardware failure with fracture through the taper-neck of femoral stem retained during the 1st revision surgery.Plaintiff underwent a 2nd revision surgery on (b)(6) 2022, where the stem was explanted.An osteotomy repair with kinamed cable and trochanteric 2-hole grip plate and screws were required.Plaintiff outcome is unknown.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
The device was not returned for evaluation but the reported event could be confirmed since the x-ray showed hardware failure with fracture through the neck of the left hip arthroplasty and proximal migration of the left femoral shaft.The clinical/medical investigation concluded that, with the information provided, the clinical root cause of the reported femoral stem fracture cannot be confirmed.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted 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 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 traumatic injury or surgical technique.The contribution of the device to the reported event could be corroborated as the device was broken and it was required a revision surgery to treat this event.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: SYN POR HO FEM COM SZ 13
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 15104364
• Report Number: 1020279-2022-03468
• Device Sequence Number: 17436929
• Product Code: LPH
• UDI-Device Identifier: 03596010291974
• UDI-Public: 03596010291974
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2020
• Device Model Number: 71306113
• Device Catalogue Number: 71306113
• Device Lot Number: 10EM06669A
• 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: 06/30/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2010
• 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: Required Intervention
• Patient Sex: Male