MAUDE Adverse Event Report: TORNIER INC ASCEND PTC HUMERAL STEM SIZE 4A; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	7503304A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Muscle/Tendon Damage (4532)
Date of Event	12/18/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a revision surgery was underwent due to a rotator cuff insufficiency.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device disposition is unknown.
Additional Manufacturer Narrative
Please note the corrections made to the h6 device code and clinical signs code: the reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.But based on the event description which mentions that "revised due to rotator cuff insufficiency" and based on the ifu which mentions that " the aequalis ascend shoulder system is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.", the probable root cause of this event is probably due to the patient condition.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that there was a revision surgery was underwent due to a rotator cuff insufficiency.

• Brand Name: ASCEND PTC HUMERAL STEM SIZE 4A
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16782288
• Report Number: 0001649390-2023-00064
• Device Sequence Number: 12121535
• Product Code: KWS
• UDI-Device Identifier: 00846832060535
• UDI-Public: 00846832060535
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K120794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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: Lay User/Patient
• Device Model Number: 7503304A
• Device Catalogue Number: 7503304A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female