MAUDE Adverse Event Report: ZIMMER GMBH SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 42-15

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); No Information (3190)
Date of Event	10/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on an unknown side and underwent revision surgery due to unknown reasons.
Additional Manufacturer Narrative
Additional information which was received on oct 14, 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additionals: b4, b5, g4, g7, h1, h2, h10.Corrections: b3.The manufacturer received other source documents for review.Should any additional information become available or an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on an unknown side and underwent revision surgery due to persistent pain and functional shoulder deficit.
Additional Manufacturer Narrative
Investigation results were made available.Review of event description: it was reported that the patient received a sidus implant on (b)(6) 2013 and underwent revision surgery on (b)(6) 2016 at a different hospital due to persistent pain starting on (b)(6) 2015 and functional shoulder deficit.The reported event was identified during a clinical study.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Patient data: patient id: (b)(6), female, born 1942, 90 kg.Otherwise, neither patient nor medical records were obtained.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as not all involved components are known.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: neither patient nor medical records such as x-rays, surgical records or visit notes were obtained; therefore, the exact sequence of events is unknown.Neither the products nor pictures of the revised products were received.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a non-conformance or a complaint out of box (coob).Due to the lack of information, the missing medical records and the unavailability of the products, no exact investigation could be carried out.Therefore, the exact reason for the revision and its cause could not 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).
Event or Problem Description
No event update.Investigation results are now available.
Event or Problem Description
Patient was implanted on an unknown side and underwent revision surgery due to persistent pain and functional shoulder deficit.
Additional Manufacturer Narrative
Additional information was received on oct 07, 2020.The manufacturer received x-rays, other source documents (surgical reports, photos) for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 42-15
• Common Device Name: SIDUS STEM-FREE SHOULDER, HUMERAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10513605
• Report Number: 0009613350-2020-00398
• Device Sequence Number: 3868989
• Product Code: KWS
• UDI-Device Identifier: 00889024415928
• UDI-Public: 00889024415928
• 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
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/14/2021

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: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.04555.420
• Device Lot Number: 2716927
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 10/07/2020; 10/14/2020; 01/04/2021
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/14/2020; 10/23/2020; 01/14/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 90