MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMF STEM WITH STIKTITE SZ 2; PRSTHSS,HIP,SM-CONSTRAINED,METAL/POLYMER,POROUS UNCMNTD

Model Number	71352502
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Erosion (1750); Failure of Implant (1924); Injury (2348); Metal Related Pathology (4530)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed in the right hip due to recurrent instability, secondary to right hip with altr as a consequence of trunnionosis of the femoral component.Liner, cup, stem and femoral head were removed.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation.The pictures provided were reviewed and the dislocation was confirmed.The clinical/medical investigation concluded that, the clinical information provided, of the altr (adverse local tissue reaction) due to trunnionosis of the femoral component may be the root cause of the tissue necrosis, dislocations and the revision.Trunnionosis is a known complication of hip surgeries, it is a type of corrosion and wear at the head-neck taper junction of the femoral implant, and it can be a slow and silent.A review of the complaint history did not reveal additional complaints for the listed batch.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 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.Possible causes could include but not limited to traumatic injury, joint tightness, patient anatomy or abnormal loading of limb.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.

• Brand Name: SMF STEM WITH STIKTITE SZ 2
• Common Device Name: PRSTHSS,HIP,SM-CONSTRAINED,METAL/POLYMER,POROUS UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10383434
• Report Number: 1020279-2020-03819
• Device Sequence Number: 3669182
• Product Code: LPH
• UDI-Device Identifier: 03596010619587
• UDI-Public: 03596010619587
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: 71352502
• Device Catalogue Number: 71352502
• Device Lot Number: 11DM01002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 08/20/2021
• 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: R3 0 DEG XLPE ACET LNR 36MM X 52MM/11KM01546; R3 3 HOLE ACET SHELL 52MM/ 11MM10618
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention