MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 5-6 9; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71421515
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that there was a potential insert peg (unknown orthopedic reconstruction device) breakage.This is a reoccurring complaint - happened 3 times previously for same customer.Further information is unknown.
Additional Manufacturer Narrative
D1: brand name added.D4: catalog number and udi added.E1, e2, e3, e4: initial reporter information added.Case-2021-00078701-1 b4: event description updated.H6: health effect - impact code updated.
Event or Problem Description
It was reported that, after a tka surgery performed on (b)(6) 2010, the genesis ii posterior stabilized high flexion insert size 5-6 9mm broke.A revision surgery was performed on (b)(6) 2021 to exchange the device.Current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the root cause of the reported breakage cannot be definitively concluded.It was noted per case details ¿the patient had no history of injury or trauma that could cause the poly insert peg to break.¿ the patient impact beyond the reported device breakage and revision with poly exchange could not be determined.The patient¿s current health status was not provided.No further clinical/medical assessment could be rendered.A review of complaint history revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.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.
Additional Manufacturer Narrative
D4: lot number and expiration date added.H4: device manufacture date added.
Additional Manufacturer Narrative
Section h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was found to be fractured along the post of the device, rendering it inoperable.The fractured post was also returned with the device.The surface of the device is also discolored likely from exposure to bodily fluids.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that based on the information provided, the root cause of the reported breakage cannot be definitively concluded.It was noted per case details ¿the patient had no history of injury or trauma that could cause the poly insert peg to break.¿ the patient impact beyond the reported device breakage and revision with poly exchange could not be determined.The patient¿s current health status was not provided.No further clinical/medical assessment could be rendered.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.According with inspection procedure, the final inspection includes the verification of part configuration per print.Also, material specification shall control the quality and manufacture of ultra-high-molecular-weight polyethlylene.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Factors that could contribute to the reported event include traumatic injury, overuse, size selected, surgical technique or postoperative care.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII PS HI FLEX ISRT SZ 5-6 9
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 12811941
• Report Number: 1020279-2021-08135
• Device Sequence Number: 19999068
• Product Code: JDG
• UDI-Device Identifier: 03596010492371
• UDI-Public: 03596010492371
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/10/2022

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
• Device Expiration Date: 09/15/2019
• Device Model Number: 71421515
• Device Catalogue Number: 71421515
• Device Lot Number: 09JM09736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 11/19/2021; 02/15/2022; 02/15/2022; 10/05/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 11/19/2021; 02/16/2022; 09/05/2022; 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2019
• 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
• Patient Sex: Unknown