MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN RSA REUNION GLENOID BASEPLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_SEL

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Loss of Range of Motion (2032); Metal Related Pathology (4530); Implant Pain (4561)

Event Date 01/28/2022

Event Type  Injury  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Disposed by hospital.

Event Description

As reported; "surgeon had a patient come in 2 weeks ago that had a reverse total shoulder reunion done at a different facility.The patient presented with shoulder stiffness and a lot of pain.X-rays showed aseptic loosening and surgeon suspected deep infection.During the surgery the surgeon noticed extreme metallosis on the glenoid side of the implant and he cleaned it all out by hand without instrumentation where the 2 peripheral screws stayed inside the glenoid and did not come out of the baseplate.Took all the implants out.After the case, upon close inspection of the glenoid baseplate he noticed that the peripheral screws where they lock into the baseplate through the threads had worn away due to aseptic loosening and infection.This had worn all the way through and the screws had pulled all the way through the baseplate.All implants were removed from the shoulder and a cement antibiotic spacer was put in.Surgeon reported that the patient is very happy with the outcomes.Implants were discarded by the hospital.No additional information is available.".

Manufacturer Narrative

Correction to h6 device code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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 was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

As reported; "surgeon had a patient come in 2 weeks ago that had a reverse total shoulder reunion done at a different facility.The patient presented with shoulder stiffness and a lot of pain.X-rays showed aseptic loosening and surgeon suspected deep infection.During the surgery the surgeon noticed extreme metallosis on the glenoid side of the implant and he cleaned it all out by hand without instrumentation where the 2 peripheral screws stayed inside the glenoid and did not come out of the baseplate.Took all the implants out.After the case, upon close inspection of the glenoid baseplate he noticed that the peripheral screws where they lock into the baseplate through the threads had worn away due to aseptic loosening and infection.This had worn all the way through and the screws had pulled all the way through the baseplate.All implants were removed from the shoulder and a cement antibiotic spacer was put in.Surgeon reported that the patient is very happy with the outcomes.Implants were discarded by the hospital.No additional information is available.".

• Brand Name: UNKNOWN RSA REUNION GLENOID BASEPLATE
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13642871
• MDR Text Key: 288357649
• Report Number: 0008031020-2022-00079
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

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: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 03/01/2022
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 04/29/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male