MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-3; ANATOMICAL SHOULDER INVERSE/REVERSE

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy date detail of product: - item number: 0104440068, item name: glenosphere, 36 0â°, lot#: 2978645.- item number: 0104440077, item name: taper adaptor, l, 0â°, lot #: 2977717.- item number: 0104223106, item name: anatomical shoulder reverse, humeral cup, 0â°, retro, +6 mm medial offset, lot #: 2988982.The manufacturer received x-rays and other source documents for review.The manufacturer did not receive the device for investigation.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
It was reported that patient underwent revision surgery due to dislocation.
Additional Manufacturer Narrative
Investigation results were made available.Event description: - event summary: it was reported that the patient had a revision surgery on (b)(6) 2019 and was revised again on (b)(6) 2019 due to recurrent dislocations.Review of received data: -summary of clinical history: the following clinical history can be summarized from the surgical reports of (b)(6) 2019, (b)(6) 2019 and (b)(6) 2019 and the according product stickers as well as the per.- 1984 polytrauma due to motorcycle accident - (b)(6) 2001 implantation of a total shoulder prosthesis (type anatomica cemented) left due to progressing destruction of the shoulder joint with necrosis of the humeral head - (b)(6) 2019 revision of the total shoulder prosthesis left and implantation of a total shoulder prosthesis inverse / reverse (anatomical stem cemented with humeral cup and insert and anaverse glenoid with baseplate, screws, taper adaptor and glenosphere) at (b)(6) balgrist, prof.Gerber.The patient has obesity permagna.At revision moderate metalosis is found and the polyethylene is worn.On the humeral side a new stem is cemented into the existing stable cement.There are difficult space conditions on the glenoid side.- (b)(6) 2019 revision of the total shoulder prosthesis left due to disassociation of the anaverse glenosphere including the taper adaptor, removal of anaverse glenosphere and taper adaptor as well as anatomical humeral cup and insert and implantation of new, identically sized components at (b)(6) balgrist, prof.Gerber during revision as expected the glenosphere including the adaptor is found disassociated from the baseplate.The latter is stable.Both tapers (adaptor as well as baseplate) are inconspicuous.The humeral insert is slightly worn and removed.Afterwards the glenosphere together with the adaptor is impacted again using the heavy hammer.Finally, neither with the distractor nor with the hook the glenosphere can be removed; also with the removal instrument it is only with the greatest effort possible to remove the now very well fixed glenosphere what is finally successful after several attempts.Therefore, it is assumed that a technical error consistent with an improperly impacted glenosphere respectively adaptor occurred at the initial surgery.- (b)(6) 2019 revision of the total shoulder prosthesis left due to recurrent dislocations, removal of anaverse glenosphere and taper adaptor as well as anatomical humeral cup and insert and implantation of new components of other size (anaverse glenosphere and taper adaptor as well as anatomical humeral cup and insert) at (b)(6) balgrist, prof.Gerber the patient experienced recurrent dislocations during mobilization.The goal of the revision is to increase the tension.If this is not possible a hemiprosthesis could be implanted.- (b)(6) 2019 - after this event: revision of the total shoulder prosthesis left due to chronic instability / dislocation, removal of implants from glenoid and filling of the peg hole with bone graft substitute, removal of anatomical humeral cup and insert and implantation of anatomical bipolar head at (b)(6) st.Gallen, prof.Jost x-rays: all received images are photos taken from the screen displaying the respective investigation.None of the x-rays address the timeframe of the concerned products of this complaint.Devices analysis: this complaint was created based on the patient history received with (b)(4).The explants of this complaint were not available for investigation.Review of product documentation: - all involved 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: after primary implantation of a left total shoulder prosthesis in 2001 the patient had four revision surgeries between may and september 2019.The first revision was performed to replace the implants placed during primary surgery in 2001.Afterwards the glenoid glenosphere including the taper adapter disassociated from the baseplate and had to be revised on (b)(6) 2019.Thereafter, recurrent dislocations occurred and a third revision had to be performed on (b)(6) 2019 this complaint was created for the components implanted on (b)(6) 2019 and revised on (b)(6) 2019.It is stated that the patient experienced recurrent dislocations during mobilization.The goal of the revision was to increase the tension.As no x-ray address the timeframe of the concerned products of this complaint, any contributing factors such as positioning and size of the implants cannot be evaluated.The explants of this complaint were not available for investigation.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The investigation results did not identify a non-conformance or a complaint out of box (coob).The reasons for dislocation are multifactorial, with contributing factors from the patient, the implant, and the surgical procedure.However, based on the information received, the reason for the chronic instability and the dislocation as well as possible contributing factors, e.G.Patient and / or surgery related, remain unknown.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
Investigation result is available now.

• Brand Name: ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-3
• Common Device Name: ANATOMICAL SHOULDER INVERSE/REVERSE
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9104351
• Report Number: 0009613350-2019-00575
• Device Sequence Number: 2487074
• Product Code: KWS
• UDI-Device Identifier: 00889024481381
• UDI-Public: 00889024481381
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K053274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.363
• Device Lot Number: 2990537
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 07/31/2020
• 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: Hospitalization; Required Intervention
• Patient Weight: 155