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

Model Number 71365705

Device Problem Separation Failure (2547)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2022

Event Type  Injury  

Event Description

It was reported that, during a thr surgery, using the anthology inserter poster hard, the surgeon impacted the redapt slvls mono stem 240mm sz 17 so, reaching the limit he would like.Then tried to disconnect the impactor from the femoral implant and it did not release for anything, so it was necessary to remove the femoral implant and re-grind the femoral canal.The procedure was completed, without delay, using a s+n back-up implant with a larger diameter.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

The device was not returned for evaluation but a video was provided and reviewed and according to the clinical team it appears to show that the inserter lever is not raised which is to allow for the pommel to unscrew and release the instrument.It is unknown if the lever was stuck in the closed position or if the instruments were used correctly.The redapt revision stem surgical technique implant assembly and insertion steps cautions that the pommel assembly should be secure/not overtightened as may cause lock-up during repeated impacting and also to inspect the inserter prior to use.Additionally, the clinical/medical investigation concluded that, based on the information provided, user technique cannot be ruled out as a potential contributing factor as the video appears to show that the inserter-lever is not raised to allow for the pommel to unscrew and release the instrument.The redapt revision stem surgical technique implant assembly and insertion steps cautions that the pommel assembly should be secure/not overtightened as may cause lock-up during repeated impacting and also to inspect the inserter prior to use.However, it is unknown if the lever was stuck in the closed position.Reportedly, there was ¿no damage caused, patient's health condition is stable, no surgical delay reported¿.No clinical factors have been identified which would have contributed to the reported event.The assess patient impact included the reported failure of device to disconnect followed by the unplanned intraoperative (revision-stem) removal, ¿re-grind¿/additional reaming, and replacement with a larger-diameter s+n backup stem to complete the revision procedure.There is also an anticipated transient rehabilitation phase; however, further patient impact cannot be determined.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 reason to suspect that the product failed to meet any product 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.A contribution of the devices to the reported event could be corroborated as a back up device was required to complete the procedure.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.

Manufacturer Narrative

Additional information: d9, h3, h6: the associated device was returned and evaluated.A visual inspection reveals some signs of wear and use.A functional evaluation reveals the threading on the tip is damaged causing the device not to connect to a mating device as intended.The reported event could be confirmed.The clinical/medical evaluation concluded that based on the information provided, user technique cannot be ruled out as a potential contributing factor as the video appears to show that the inserter-lever is not raised to allow for the pommel to unscrew and release the instrument.The redapt revision stem surgical technique implant assembly and insertion steps cautions that the pommel assembly should be secure/not overtightened as may cause lock-up during repeated impacting and also to inspect the inserter prior to use.However, it is unknown if the lever was stuck in the closed position.Reportedly, there was ¿no damage caused, patient's health condition is stable, no surgical delay reported¿.No clinical factors have been identified which would have contributed to the reported event.The assess patient impact included the reported failure of device to disconnect followed by the unplanned intraoperative (revision-stem) removal, ¿re-grind¿/additional reaming, and replacement with a larger-diameter s+n backup stem to complete the revision procedure.There is also an anticipated transient rehabilitation phase; however, further patient impact cannot be determined.No further medical assessment can be rendered at this time.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.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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 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.A review of the instructions for use file is not applicable for this instrument.As the device can no longer fit its purpose, the contribution of the device to the reported event could be corroborated.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 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.H6, h10.

• Brand Name: ANTHOLOGY INSERTER POSTER HARD
• Type of Device: 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: 15461743
• MDR Text Key: 300309150
• Report Number: 1020279-2022-04131
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010555663
• UDI-Public: 03596010555663
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K113789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 71365705
• Device Catalogue Number: 71365705
• Device Lot Number: 19AM06476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/21/2022
• Supplement Dates Manufacturer Received: 10/13/2022; 02/03/2023
• Supplement Dates FDA Received: 10/19/2022; 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: REDAPT SLVLS MONO STEM 240MM SZ 17 SO, LOT#:19BTM0
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male