MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 24MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5572-4524
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Reaction (2414)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "patient received a primary rsa on (b)(6) 2016, with no issues.Patient came back and had a shoulder scope on (b)(6) 2019, which presented what appeared to be visible metallosis.Patient then came back on (b)(6) 2019 to have his rsa removed and have a shoulder spacer implanted." additionally reported: "tissue was sent to the lab and metallosis, as well as p acnes were confirmed.Patient currently an antibiotic spacer implanted with gent/vanc cement around the head/neck junction.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the intraoperative pictures provided confirm the event that metallosis affected the tissues surrounding the device.Black tissues / deposits surround the baseplate as well as the screws in it.In this case, the opinion of a medical expert was request to determine the root cause of the reported metallosis.His statement based on the information provided states: "[.] the literature talks about the varying corrosive effects of anodized titanium, relating to the thickness and color of the anodized layers.At a fracture site, wolff¿s law is occurring with a generation of an electrical current, although very slight, the current occurs within the solutions around the plate and soft-tissue and will corrode to metal surface.It is the interaction of an inorganic material, and soft tissue and the degree of roughness of the implant surface, the methods utilized in achieving the surface topography, and the chemistry of implant materials, are some of the factors that may affect the soft tissue response of the plate to the adjacent soft tissue and create the grayish color.There has been no risk reported with this corrosive action since the levels of local metal ions and systemic ions is usually at very low levels in these cases.In case of high levels of metal ions, risks have been reported associated with local soft tissue damage, delayed hypersensitivity reaction (type iv) and systemic toxicity.[.]" as a summary, the appearance of the metallosis can be attributed to patient factors and the result of how the patient reacted to the device.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 any further information is provided, the investigation report will be updated.
Event or Problem Description
As reported: "patient received a primary rsa on (b)(6) 2016, with no issues.Patient came back and had a shoulder scope on (b)(6) 2019, which presented what appeared to be visible metallosis.Patient then came back on (b)(6) 2019 to have his rsa removed and have a shoulder spacer implanted." additionally reported: "tissue was sent to the lab and metallosis, as well as p acnes were confirmed.Patient currently an antibiotic spacer implanted with gent/vanc cement around the head/neck junction.".

• Brand Name: 4.5MM PERIPHERAL SCREW - 24MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9862618
• Report Number: 0008031020-2020-00774
• Device Sequence Number: 2787147
• Product Code: KWS
• UDI-Device Identifier: 07613327098730
• UDI-Public: 07613327098730
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

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: 11/30/2020
• Device Model Number: 5572-4524
• Device Catalogue Number: 5572-4524
• Device Lot Number: 662N5R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR