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

Catalog Number	5572-2800
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Osteopenia/ Osteoporosis (2651)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "peripheral screw pulled through the baseplate locking mechanism.Baseplate was pulled out of patient, while one of the peripheral screws remained intact in the patients glenoid." ----------------------------------------------------------------------------------------------------------------- update 04 feb 2024: initial surgery took place on (b)(6) 2021.Surgeon was concerned about calcar bone loss, so modified an implant and cemented a long stem.Standard baseplate and tuberosity repair revision surgery details: the glenoid was loose.Glenosphere appeared still on the baseplate, but the screw went through in the soft tissues.Patient was revised to a hemiarthroplasty.Very medically unwell (poor medical status and weird presentation (bone loss - osteoporosis)) patient could have a neuropathic shoulder from his cervical spine, which could explain loosening.Devices successfully removed.
Additional Manufacturer Narrative
Corrections: b5 executive summary.D4 lot number.Catalog number.D4 gtin.G4 510k number.The reported event was confirmed since the migrated peripheral screw is visible on the received xrays.The device inspection revealed the following the visual inspection of the baseplate has shown that one of the four peripheral screw holes is strongly widened up the hole is that big that the screw head falls through the hole it is clear that the screw that was pulled through the plate was inserted into this hole the closer inspection of the damaged hole shows that the locking lip is totally flattened on one side with a burr on top and there are strong stress marks on top of the hole these damages were most likely caused by an excessive contact with the drill bit during drilling the inspection of the of the 32mm peripheral screw which was pulled through the plate has shown that the thread flanks are intact this shows that the previously described excessive damages at the baseplate hole were not caused by the screw there is just a slight stress mark on one side of the screw head this small area was most likely the only slight contact between the screw and the plate after the screw was inserted into the damaged hole a functional test with both returned peripheral screws was performed both screws could be locked into the intact baseplate holes without any issues as stated before is the damaged hole that big that the screw heads fall through the hole which makes a proper function impossible.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.The complaint was forwarded to medical affairs for review with following result based on the available information it appears that several factors contributed to the outcome these include compromised bone quality the drilling and widening of the screw hole beyond optimal dimensions utilization of fewer screws than recommended and the placement of screws notably the absence of a screw in the inferior peripheral hole consequently the glenoid baseplate was primarily supported by only one central screw and one shorter peripheral screw rendering the elongated screw functionally redundant due to the oversized hole it was placed in.Based on investigation the root cause was attributed to a user related issue.In relation to drilling and screw placement following statements of the reunion rsa reverse shoulder arthroplasty system operative technique can be mentioned place the variable angle peripheral drill guide into the glenoid baseplates inferior hole the drill guide can be angled up to a maximum angle of 15 but should always be engaged fully in the glenoid baseplate hole while firmly holding the peripheral drill guide against the glenoid baseplate begin drilling through the subchondral bone to the desired optimal depth using the 31mm drill bit.Axial pressure should be maintained on the drill guide throughout the entire drilling process to ensure proper seating of the drill guide to the baseplate.Caution: the required minimum number of screws shall be no less than two 2 peripheral screws superior and inferior and one 1 center screw.When possible four 4 peripheral and one 1 center screw should be used.If more information is provided the case will be reassessed.
Event or Problem Description
As reported: "peripheral screw pulled through the baseplate locking mechanism.Baseplate was pulled out of patient while one of the peripheral screws remained intact in the patients glenoid.".Update provided on a different date.Initial surgery took place on a later date surgeon was concerned about calcar bone loss, so modified an implant and cemented a long stem.Standard baseplate and tuberosity repair.Revision surgery details: the glenoid was loose.Glenosphere appeared still on the baseplate, but the screw went through in the soft tissues.Patient was revised to a hemiarthroplasty very medically unwell (poor medical status and weird presentation (bone loss - osteoporosis)).Patient could have a neuropathic shoulder from his cervical spine which could explain loosening.Devices successfully removed.

• Brand Name: BASEPLATE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18936397
• Report Number: 0008031020-2024-00124
• Device Sequence Number: 15214618
• Product Code: KWS
• UDI-Device Identifier: 07613327098709
• UDI-Public: 07613327098709
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K202289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 5572-2800
• Device Lot Number: DY0MXD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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 Sex: Prefer Not To Disclose