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

Catalog Number	71352502
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tha surgery of the right hip performed on (b)(6) 2015, the patient experienced a failed tha.This condition was treated by a performing a revision surgery of the right hip on (b)(6) 2023, during which the stem, the modular neck, the femoral head and the liner were explanted and replaced with a smith and nephew liner and a biolox delta femoral head with an arcos 150mm sts stem.During the surgery, there was clear metallosis/tendinosis type wear at the modular junction where the modular neck meets the stem.Throughout the case there was pseudotumor and fluid that was debrided, including the medial tissues distal to the lesser trochanter.After the surgery, the patient was transferred to the recovery room in a stable condition, he will be toe-touch weight-bearing.No further complications reported.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, with the information provided the clinical root cause of the reported pseudotumor, and metallosis/tendinosis type wear cannot be confirmed.It cannot be concluded the reported clinical reactions were associated with a mal performance of the implant.The patient impact beyond the revision cannot be determined with the limited information provided.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of the instructions for use documents for total hip systems revealed in the adverse events in primary and revision surgery section that although rare, metal sensitivity reactions and/or allergic reactions to foreign materials have been reported in patients following joint replacement, which have required device removal.A review of the risk management files 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 these products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include irregular implant interaction, wear, abnormal motion over time or patient condition.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: SMF STEM WITH STIKTITE SZ 2
• 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: 17950793
• Report Number: 1020279-2023-01959
• Device Sequence Number: 12441313
• Product Code: LPH
• UDI-Device Identifier: 03596010619587
• UDI-Public: 03596010619587
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

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: 06/02/2023
• Device Catalogue Number: 71352502
• Device Lot Number: 12HM12965B
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71335552 / LOT: 15EM10355; PN: 71335752 / LOT: 15CM11799; PN: 71343612 / LOT: 12JM17143; PN: 71352112 / LOT: 13JTM0016C
• Patient Age: 74 YR
• Patient Sex: Male