MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. REVERSE BODY LRG; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number BOD096008LRG

Device Problem Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, during a reverse total shoulder surgery, a morse taper disengaged from a reverse body lrg, therefore a glenoid body and stem dissociated.At which point both implants were extracted.The implants were attempted to be re-mated but the morse taper again did not hold.The implants were explanted.Surgery was resumed, after a non-significant delay, with smith and nephew back-up devices.

Manufacturer Narrative

H3, h6: the reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the reverse body lrg.Therefore, no investigation is deemed for the other device.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that clinical documentation had not been received; therefore there were no clinical factors found which would have definitively contributed to the event.The current patient status is unknown.Patient impact beyond the disengaged morse taper/dissociated stem with component extraction, use of back-up components and the surgical delay 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 based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for titan¿ total shoulder system and titan¿ reverse shoulder system revealed that loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and/or excessive activity.This has been identified as an adverse event.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 specifications at the time of manufacture.Factors that could contribute to the reported event include size selected or insertion technique.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

H6: although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the reverse body large.The associated device was returned and evaluated.Visual evaluation of the reverse body large and tss press fit stem sz.11 did not identify any visual defects.Minor cosmetic marks were noticed and expected as a result of attempted assembly and implantation.The complaint alleges that a morse taper disengaged from a reverse body large, therefore a glenoid body and stem dissociated.The implants were attempted to be re-mated, but the morse taper again did not hold.The implants were explanted.Based on the information provided, the unsatisfactory experience could be confirmed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Functional evaluation of the returned product was conducted by attempting to replicate the reported failure.The complaint alleges that a morse taper disengaged from a reverse body large, therefore a glenoid body and stem dissociated.The implants were attempted to be re-mated, but the morse taper again did not hold.The implants were explanted.Per the surgical technique, the devices are assembled by seating and securing the reverse body implant onto the rss stem impaction stand.The humeral stem implant is placed into the reverse body with finger pressure.Then, the stem impactor is placed over the tip of the humeral stem and engages the tapers with a few mallet strikes.The body screw is not placed until after implantation.The tss press fit stem and reverse body were assembled to see if the device would disengage.The devices would not disengage, and the reported failure could not be replicated.Additionally, the body screw was not included in the return.Based on functional evaluation, a root cause could not be determined.A review of complaint history based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total shoulder system and titan reverse shoulder system revealed in the adverse events section that loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and/or excessive activity.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.Factors that could contribute to the reported event include size selected or insertion technique.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 for future complaints and investigate as necessary.We consider this investigation closed.D8 / d9 - device returned to manufacturer.H5- labeled for single use.

Manufacturer Narrative

H3, h6: the associated devices were returned and evaluated.A visual evaluation of the reverse body large and tss press fit stem sz.11 did not identify any visual defects.Minor cosmetic marks were noticed and expected as a result of attempted assembly and implantation.A functional evaluation of the returned product was conducted by attempting to replicate the reported failure.The tss press fit stem and reverse body were assembled to see if the device would disengage.The devices would not disengage, and the reported failure could not be replicated.Additionally, the body screw was not included in the return.Based on the functional evaluation, a root cause could not be determined.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the reverse body large.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 based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for titan¿ reverse shoulder system revealed that a surgical technique brochure is available which outlines the basic procedure for device implantation and use of the specialized surgical instrumentation.It is the responsibility of the surgeon to be familiar with the procedure before use of these products.Additionally, meticulous selection of the proper size implant increase the potential for successful reconstruction.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.However, based on the information provided, the unsatisfactory experience could be confirmed.Factors that could contribute to the reported event include size selected or insertion technique.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: REVERSE BODY LRG
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18077932
• MDR Text Key: 327444297
• Report Number: 3002788818-2023-00093
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/23/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: BOD096008LRG
• Device Lot Number: QJ1391
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 11/16/2023; 05/10/2024; 08/22/2024
• Supplement Dates FDA Received: 11/17/2023; 05/16/2024; 08/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STEM-0920-025-11 / LOT# 272618-10.
• Patient Outcome(s): Required Intervention