MAUDE Adverse Event Report: STRYKER GMBH PRESS-FIT HUMERAL STEM 14MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5567-P-3014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that a case done 6 weeks for the removal of a stryker shoulder stem has metallosis.
Event or Problem Description
It was reported that a case done 6 weeks for the removal of a stryker shoulder stem has metallosis.
Additional Manufacturer Narrative
The reported event could not be confirmed.The device inspection revealed the following: the identification of the device was confirmed based on the catalog # and the lot # marked.The coated part of the stem is heavily worn out, with multiple scratches, occurring most probably during explantation.Bone can also be observed on the coated surface, giving indication of osseointegration.One of the holes of the stem is worn out, indicating that the implant may have been not fully aligned or correctly assembled with the broach during the press-fit insertion.The wear observed may have led to the creation of metal debris in the patient.Despite the observations made, the device itself does not give evidence of the reported metallosis as no picture of the patient was received.It was not possible to link the implant wear and the possible creation of metal debris with the reported metallosis, as not enough information was provided in this case.Studies concluded that the "metal wear particles consisting of tiaiv are typically very small (a mean size of 0.1 +/- 0.15 micron) in order to be able to provoke such a response".In the event at hand, the sizes of the particles are not an information that has been provided.Furthermore, as indicated by medical experts, "metallosis is about the type-iv immune response to the accumulation of metal particles within tissues.There are cases of early arthroplasty failure due to metallosis, yet these patients usually do well initially and start to get pain and joint stiffness after months, leading to revision within 2 years.".However, the reported metallosis was observed after 6 weeks of implantation, a post-surgical lapse of time much shorter than what is usually observed for such response.This gives further indication of the lack of evidence pointing towards metallosis and the impossibility to confirm the reported event.Based on investigation, the root cause was attributed to an user related issue.The wear observed on the implant is most probably related to mishandling of the device during implantation and explantation.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 more information is provided, the case will be reassessed.

• Brand Name: PRESS-FIT HUMERAL STEM 14MM
• 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: 15734095
• Report Number: 0008031020-2022-00571
• Device Sequence Number: 15009036
• Product Code: KWS
• UDI-Device Identifier: 07613327424812
• UDI-Public: 07613327424812
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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: 5567-P-3014
• Device Catalogue Number: 5567-P-3014
• Device Lot Number: G7817127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2020
• 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: Unknown