MAUDE Adverse Event Report: GLENOID, PE WITH PEG, SMALL; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	GLENOID, PE WITH PEG, SMALL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that a glenoid component removal had to be performed as a revision surgery due to an aseptic loosening of the device.No further information received.Update 31-mar-2021: further information was received.X-rays and pictures were provided containing the part- and lot-no.Of all involved devices (ar-9105-01/lot 1246018, ar-9301-02/lot 2501252307, ar-9300-41cpc/lot 2501241206, cd-9341-16/1242003), which were primary implanted on the (b)(6) 2013.The date of incident was confirmed to be the (b)(6) 2021 although the patient has experienced the correspondingly large burden on her shoulders already for many years, but had to care for her severely disabled husband.After the husband passed away, the patient decided to have the operation.During the revision a filling with bone substitute cerament (hemi) was performed to treat the patient.
Additional Manufacturer Narrative
Complaint not confirmed, light damage was observed on the teeth of the pegs and keel and along the edges of the device, but no abnormalities were observed that may have contributed to the event.Bone cement was observed on the central peg and on the keel.

• Brand Name: GLENOID, PE WITH PEG, SMALL
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• MDR Report Key: 11612657
• Report Number: 1220246-2021-02832
• Device Sequence Number: 19719475
• Product Code: KWS
• UDI-Device Identifier: 00888867057319
• UDI-Public: 00888867057319
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: Health Professional
• Device Model Number: GLENOID, PE WITH PEG, SMALL
• Device Catalogue Number: AR-9105-01
• Device Lot Number: 1246018
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR