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

Catalog Number 71352502

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Laceration(s) (1946); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530); Unequal Limb Length (4534)

Event Date 08/21/2019

Event Type  Injury  

Event Description

It was reported that after primary thr, patient presented pain in the joint and mechanical loosening of the joint prosthesis.A revision surgery was performed to explant a smf stem with stiktite sz 2, oxinium femoral head 12/14 32mm -3 and a r3 20 degree xlpe acetabular liner 32mm inner diameter x outer diameter.The outcome of the patient is unknown.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.The images provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, based on the information provided the reported pain was likely secondary to the ¿mechanical loosening¿ of the primary joint prosthesis.The time elapsed from increased symptoms onset and identification of a right hip cystic lesion likely contributed to the severity of the symptoms.The pathology report noted chronic inflammation which may be consistent with an adverse tissue reaction to metal wear debris; however, the contralateral/competitor hip pathology findings were consistent with a metal related tissue reaction to metal debris.The assessed patient impact was the reported symptoms, revision, and an expected transient post-op convalescence phase.Further patient impact could not be determined.Per jan.2021 office note, the patient was ¿within normal limits for circumstances¿.No further medical assessment could be rendered at this time.Should additional relevant clinical documentation and/or product evaluation become available in the future, the clinical/medical task may be re-evaluated.A review of 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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing and/or traumatic injury.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.

Manufacturer Narrative

H10.Additional information in b5, b6 and b7.H11.Corrected information in d6b.

Event Description

It was reported that after a primary right thr, the patient presented pain in the joint, pseudotumor formation and mechanical loosening of the joint prosthesis.A revision surgery was performed to explant a smf stem with stiktite sz 2, oxinium femoral head 12/14 32mm -3 and a r3 20 degree xlpe acetabular liner 32mm inner diameter x outer diameter.The outcome of the patient is unknown.

Manufacturer Narrative

H11: the date of the event was updated.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation but the event can be confirmed.According to the clinical/medical investigation, the reported pain was likely secondary to the ¿mechanical loosening¿ of the primary joint prosthesis.The time elapsed from increased symptoms onset and identification of a right hip cystic lesion likely contributed to the severity of the symptoms, as the pathology report noted chronic inflammation which may be consistent with an adverse tissue reaction to metal wear debris; however, the contralateral/competitor hip pathology findings were consistent with a metal related tissue reaction to metal debris.The assessed patient impact was the reported symptoms, revision, and an expected transient postop convalescence phase.Further patient impact could not be determined.No further medical assessment could be rendered 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 review of the instructions for use for this device reveal that implant loosening has been identified as an adverse event in primary and revision surgery.A historical review concluded that this event was previously identified and addressed through a voluntary market removal for the affected lots of modular neck hip prostheses due to a higher than anticipated complaint and adverse event trend, the associated stems were also removed from the market.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.The contribution of the device to the reported event could be corroborated, since the reported adverse event was resolved by the explantation of the device.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.

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, based on the information provided, the reported pain was likely secondary to the ¿mechanical loosening¿ of the primary joint prosthesis.The time elapsed from increased symptoms onset and identification of a right hip cystic lesion likely contributed to the severity of the symptoms, as the pathology report noted chronic inflammation which may be consistent with an adverse tissue reaction to metal wear debris; however, the contralateral/competitor hip pathology findings were consistent with a metal related tissue reaction to metal debris.The assessed patient impact was the reported symptoms, revision, and an expected transient post-op convalescence phase.Further patient impact could not be determined.No further medical assessment could be rendered at this time.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 reported devices revealed similar events for the part numbers over the previous 36 months, but no similar events for the batches based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed that implant loosening has been identified as an adverse event in primary and revision surgery.In the warnings and precautions/ preoperative section, it is established that the patient should be warned of surgical risks, and made aware of possible adverse effects.Additionally, in the adverse events section it was revealed 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 the acetabular shell and this event.However, for the stem and modular neck, a review concluded that a similar event was identified.The following actions were taken: the occurrence rating was updated, the risk management plans were reviewed and updated, an improved in vitro fretting testing was stablished, the applicable surgical techniques were reviewed to include the instruction to "cleaning and drying before the impaction".Smf stems were obsoleted in the system.Containment actions were taken which prevented distribution of the product.However, on 2019 modular necks were made available to revising surgeons when requested and the defined criteria is met.It was determined that the benefits of using a recalled modular neck during a hip revision surgery to replace an implanted modular neck on a stem that is remaining implanted outweigh the risks of not using a recalled modular neck.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 abnormal motion over time, bone degeneration, loss of ingrowth, osteolysis, traumatic injury, surgical assembly, neck and taper fit design, abnormal motion over time, irregular implant interaction and neck selection.Corrective and preventive actions were previously initiated.Should the devices 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
• Type of Device: 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: 11736181
• MDR Text Key: 247673573
• Report Number: 1020279-2021-03605
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/12/2024

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 Operator: Health Professional
• Device Expiration Date: 11/14/2020
• Device Catalogue Number: 71352502
• Device Lot Number: 10LM11419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 08/18/2021; 05/06/2022; 06/30/2022; 07/07/2022; 02/08/2024
• Supplement Dates FDA Received: 08/20/2021; 05/19/2022; 07/01/2022; 07/07/2022; 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0945-2017
• Patient Sequence Number: 1
• Treatment: HIGH OFFSET NEUTRAL MODULAR NECK/11CTM0010G; R3 0 HOLE ACET SHELL 50MM/11EM16750
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 46 YR
• Patient Sex: Female