MAUDE Adverse Event Report: STRYKER GMBH REUNION TSA - SR 4MM OFF SET HUMERAL HEAD 44X16; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5552-E-4416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Numbness (2415); Implant Pain (4561)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; device remains implanted in patient.
Event or Problem Description
As reported: "patient is experiencing pain and numbness in the right lateral arm, forearm, and hand and is unable to flex right elbow.Patient reports that the symptoms occurred after the pain catheter was removed.Nerve conduction study performed on (b)(6) 2020 indicates "acute right brachial plexopathy affecting all parts of the brachial plexus, but most significantly, the upper trunk.".
Event or Problem Description
As reported: "patient is experiencing pain and numbness in the right lateral arm, forearm, and hand and is unable to flex right elbow.Patient reports that the symptoms occurred after the pain catheter was removed.Nerve conduction study performed on (b)(6) 2020 indicates "acute right brachial plexopathy affecting all parts of the brachial plexus, but most significantly, the upper trunk.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The opinion of a medical expert was requested for this case, and based on the information provided in the event description, his statement is the following: " [.] the event is not device related nor is it related to the surgery.I would understand that these problems may be associated to the anesthesiology, who placed the pain catheter.[.]" therefore, based on investigation, a device related root cause can be discarded.The event was most probably due to an error on the anesthesiology front.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.

• Brand Name: REUNION TSA - SR 4MM OFF SET HUMERAL HEAD 44X16
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10672229
• Report Number: 0008031020-2020-02321
• Device Sequence Number: 2562138
• Product Code: KWS
• UDI-Device Identifier: 07613327097900
• UDI-Public: 07613327097900
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K103835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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: 5552-E-4416
• Device Catalogue Number: 5552-E-4416
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 12/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Weight: 88