MAUDE Adverse Event Report: ZIMMER GMBH SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 50-18; N/A

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	07/20/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy date detail of product: item # 0104555130, item name sidus stem-free shoulder, humeral anchor, uncemented, l, lot # 2700815.The manufacturer did not receive x-rays, or other source documents for review, neither the device has been received for investigation as the patient has not been revised.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available, an updated report will be submitted.(b)(4).
Event or Problem Description
Clinical study reported that during clinical follow-up it was found that patient having pain and radiolucency (1mm).
Event or Problem Description
No event update.
Additional Manufacturer Narrative
Investigation results were made available.Additional: h2, h6 correction: b4, g4, g7, h10 part specific investigation: less than 3 similar investigated events within the last 1 month and less than 6 similar investigated events within the last 6 months prior to the event date have been found for these item numbers.Result: issue evaluation request is not required.Lot specific investigation: less than 3 similar investigated events for the same lot numbers have been found.Result: issue evaluation request is not required.Review of event description: it was reported that the sidus was implanted on the right side on (b)(6) 2013 and during clinical follow-up after 2 and 5 years, it was found that patient is having pain and radiolucency (1mm).Patient takes daily pain medication.Review of received data: - no medical data such as x-rays or surgical notes received.- cfr report: pre-op: primary diagnosis: osteoarthritis.Bone quality: scelerotic no impact to patient on 3 months follow-up on (b)(6), 2019 no impact to patient on 6 months follow-up on (b)(6) 2014 1 year follow-up on (b)(6) 2014: patient takes daily medication.Patient reports moderate pain and discomfort.Patient reported extreme pain and 1mm radiolucency observed on 2 year follow-up on (b)(6)2015.Patient takes daily medication.Patient reported extreme pain on 5 year follow-up on (b)(6) 2018 (ases score 22.7) devices analysis: - no product was returned to zimmer biomet for in-depth analysis as it remains implanted.Review of product documentation - these devices are intended for treatment.- dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Conclusion summary: it was reported that the sidus was implanted on(b)(6) 2013 and during clinical follow-up after 1, 2 and 5 years, it was found that patient is having pain and radiolucency (1mm).Patient takes daily pain medication.The investigation results did not identify a non-conformance or a complaint out of box (coob).The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Neither x-rays nor any other medical documents were received; therefore the condition of the components is unknown.Patient factors that may affect the performance of the components such as activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol remains unknown.Moreover, pain cannot be related to a specific failure mode and can have numerous causes.Therefore, based on the available information, an exact root cause cannot be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 50-18
• Common Device Name: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8925713
• Report Number: 0009613350-2019-00522
• Device Sequence Number: 2048295
• Product Code: HSD
• UDI-Device Identifier: 00889024415973
• UDI-Public: 00889024415973
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: foreign,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.04555.500
• Device Lot Number: 2643676
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Weight: 144