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

Catalog Number 5572-2800

Device Problems Device Abrasion From Instrument Or Another Object (1387); Device Slipped (1584); Extrusion (2934); Material Integrity Problem (2978); Scratched Material (3020); Unintended Movement (3026)

Patient Problem Unspecified Infection (1930)

Event Date 10/13/2015

Event Type  Injury  

Manufacturer Narrative

The following other devices were also listed in this report: 4.5mm peripheral screw - 24mm; cat# 5572-4524; lot# mnm4m0; 4.5mm peripheral screw - 24mm; cat# 5572-4524; lot# mnekdh; 4.5mm peripheral screw - 24mm; cat# 5572-4524; lot# mnma75; 4.5mm peripheral screw - 28mm; cat# 5572-4528; lot# mnllne; humeral cup - 36mm dia x 4mm thk; cat# 5570-3604; lot# mnj9aw; reunion tsa - press-fit humeral stem 13mm; cat# 5569-p-2013; lot# 2336hx; glenosphere - 36mm dia x 2mm thk 2mm eccentric; cat# 5573-2e-3602; lot# mnj17l; 6.5mm center screw - 24mm; cat# 5573-6524; lot# 1k314k.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.When completed, the investigation results will be submitted in a supplemental report.

Event Description

Sales rep reported: dr.(b)(6) notified me of revision he wanted to do on mr.(b)(6).At that time all implants were still intact with no loosening.He again showed me x-rays in (b)(6) which showed loosening and it appeared the screws had come through the glenoid baseplate.(b)(6) 2015 revision was performed and the patient had an infection and all implants were removed and antibiotic cement spacer was inserted.

Manufacturer Narrative

The following device was added to this report after submission of the initial report: x3 humeral insert - 36mm x 4mm standard; cat# 5571-s-3604; lot# mnhvrp.An event regarding infection involving a reverse shoulder baseplate was reported.The event was confirmed.Method & results: -device evaluation and results: a visual inspection shows the device was damaged around the screw holes.Two of the four peripheral screw holes showed significant damage that distorted the original circular shape to an oval.This deformation allowed the screws to fall through the device without locking.-medical records received and evaluation: all medical records were reviewed by a consulting clinician who found no factors of faulty design, manufacturing, or materials of the components.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no similar previous reported events for this lot id or sterile lot id.Conclusions: the exact cause of the infection could not be determined because limited patient medical records were provided for review.Additional information such as laboratory results would be required for further review.Based on a discussion with the stryker sales representative, it was noted that the dissociated screws, as seen on the x-ray, were not the reason for revision.The surgeon indicated the screws were causing no pain and no harm; the reason for revision was strictly for infection.Based on the device inspection, it is likely the primary surgeon did not use the required drill guide while prepping the glenoid or the surgeon used a powered drill to implant the screws, instead of using the mandatory manual approach.Both may result in widening of the baseplate holes, which will allow the screw to completely pass through the baseplate without locking.This is consistent with the reported event.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Sales rep reported: dr.(b)(6) notified me of revision he wanted to do on mr.(b)(6) in (b)(6).At that time all implants were still intact with no loosening.He again showed me x-rays in (b)(6) which showed loosening and it appeared the screws had come through the glenoid baseplate.(b)(6) 2015 revision was performed and the patient had an infection and all implants were removed and antibiotic cement spacer was inserted.

• Brand Name: BASEPLATE
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5208545
• MDR Text Key: 30688843
• Report Number: 0002249697-2015-03652
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 5572-2800
• Device Lot Number: MNP6WL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2014
• 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: 62 YR