MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY INSERTER ANT SOFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	71365721
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a thr surgery, while impacting an anthology so porous size 7 (femoral component), the threaded tip of an anthology inserter ant soft fractured.The broken tip was left inside the patient's body attached to the stem.The procedure resumed after a significant delay.No other complications were reported.
Additional Manufacturer Narrative
H2: additional information ¿e¿.
Additional Manufacturer Narrative
Section h10: although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the anthology inserter.The device was not returned for evaluation.However, the photographs were reviewed and revealed that the tip of the device fractured off.The clinical/medical investigation concluded that based on the information provided, the clinical root cause of the reported events could not be determined and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.It is unclear if the surgical technique were adhered to.The anthology inserter is made of stainless steel.This is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact is determined to be the retained broken anthology inserter tip.Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months 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.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
Section h10 (updated results of investigation): although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the anthology inserter.The device was not returned for evaluation.However, the photographs were reviewed and revealed that the tip of the device fractured off.The clinical/medical investigation concluded that based on the information provided, the clinical root cause of the reported events could not be determined and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.It is unclear if the surgical technique were adhered to.The anthology inserter is made of stainless steel.This is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact is determined to be the retained broken anthology inserter tip.Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months 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 instructions for use documents for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices revealed that visually inspecting for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
Additional information: d10 (femoral stem added as a concomitant), e2 (reporter is a healthcare professional), h6 (investigation conclusions).Corrected data: b1 (type of event involves also product malfunction).

• Brand Name: ANTHOLOGY INSERTER ANT SOFT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 19780198
• Report Number: 1020279-2024-01407
• Device Sequence Number: 20900209
• Product Code: LZO
• UDI-Device Identifier: 03596010553409
• UDI-Public: 03596010553409
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K113789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/25/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71365721
• Device Lot Number: UNKNOWN
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: 07/22/2024; 08/22/2024; 09/05/2024; 10/25/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 07/30/2024; 08/28/2024; 09/11/2024; 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71356007 / LOT: 23KM11318.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown