MAUDE Adverse Event Report: ZIMMER GMBH SIDUS STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, L; N/A

Model Number N/A

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results were made available.Concomitant medical products according: item: sidus stem-free shoulder, humeral head, 52-23.Catalog #: 01.04555.525, lot #: 2946819.Item: sidus stem-free shoulder, head distractor, catalog #: 01.04555.880, lot #: 4501661746.Dhr-review: ref:01.04555.525 ; lot:2946819, yield:20, delivered:20.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Ref:01.04555.130 ; lot:2943298, yield:20, delivered:20, the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: damaged product/jammed.Event description: it was reported that during the implantation surgery of sidus stemless shoulder surgeon put the implants in good position and after he needed to pop off the head in order to put the sutures.He hit the head distractor several times and head would not come off.After several hits the anchor implant loosened and came out as 1 piece with the distractor wedged between the anchor and head.Subsequently, he had to convert to a comprehensive mini stem.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: visual examination: sidus stem-free shoulder humeral anchor, sidus stem-free shoulder humeral head and the head sitractor were received stuck to each other as one piece.Several light hits on the hammer did not help to disassemble the products.Therefore stronger hammer impactions on the distractor were applied it was finally possible to disassemble the stuck items.Taper area of the anchor is observed to be damaged and also corresponding contact area on the head taper is noticed to be damaged.Head distractor shows al also noticable wear on the area where it is in contact with the anchor and head.Moreover, the areas on the outer ring of the anchor where it gets in contact with the distractor are significantly worn that the ref/lot numbers located on these areas became unreadable.Functional test: seating the received anchor on the head and removal by hand multiple times was satisfactory.Afterwards, the head distractor was utilized to remove the anchor from the head several times and it was satisfactory as well.Review of product documentation: all involved devices are intended for treatment.The compatibility check was performed and showed that the product combination was approved by zimmer biomet.Sidus stem-free shoulder surgical technique explains the relevant surgical steps revision/intra-operative correction on page 26: head removal: to remove the humeral head, slide the head distractor between the collar of the humeral anchor and the under surface of the humeral head.Firmly tap the end of the instrument to loosen the head.This instruments can be used to remove either trial head or the implant head.Conclusion summary: review of the device history records for the products did not identify any deviations or anomalies related to the reported event.The investigation results did not identify a non-conformance or a complaint out of box (coob).Based on the returned product and the given information the complaint could be confirmed.It is possible that during use of the head distractor it was rather moved up and down instead of parallel hit on the instrument leading to implants getting stuck along with the head distractor.However, a specific root cause could not be determined based on the investigation results.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2019-00135-1, 0009613350-2019-00639.

Event Description

It was reported that during the surgery the fork wedged between the anchor and head.Note: during investigation, this product has been added to this incident.Investigation results are available now.

• Brand Name: SIDUS STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, L
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9249040
• MDR Text Key: 165577910
• Report Number: 0009613350-2019-00638
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2019

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.04555.130
• Device Lot Number: 2943298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 113