MAUDE Adverse Event Report: STRYKER GMBH GLENOSPHERE - 32MM DIA X 2MM THK CONCENTRIC; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 5573-C-3202

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 02/27/2019

Event Type  Injury  

Manufacturer Narrative

Device was not returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

It was reported that a stage 1 revision of the patient's left shoulder was performed due to infection.Surgeon reported infection as (b)(6).Patient's entire shoulder construct was removed and a spacer was placed.Rep reported that the hospital and surgeon will not release any further information.

Event Description

It was reported that a stage 1 revision of the patient's left shoulder was performed due to infection.Surgeon reported infection as (b)(6).Patient's entire shoulder construct was removed and a spacer was placed.Rep reported that the hospital and surgeon will not release any further information.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.No additional information such as medical records, x-rays or surgery reports was provided although repeatedly requested due to (¿hospital policy¿).Likewise, no further information regarding the kind of infection was provided.We have received no information regarding other potential sources of infection, including but not limited to the patient or the facility.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: GLENOSPHERE - 32MM DIA X 2MM THK CONCENTRIC
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8441692
• MDR Text Key: 139536558
• Report Number: 0008031020-2019-00293
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327098877
• UDI-Public: 07613327098877
• Combination Product (y/n): N
• PMA/PMN Number: K130895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5573-C-3202
• Device Lot Number: N572DE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 107