MAUDE Adverse Event Report: ZIMMER GMBH SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 52-23

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

Concomitant medical products: item# 01.04555.130, lot# 2943298, sidus stem-free shoulder, humeral anchor, uncemented, l.Device evaluated by mfr: the complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.The manufacturer did not receive x-rays, or other source documents for review.Device history record (dhr) was reviewed and no discrepancies were found.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 Description

It was reported that during the surgery the fork wedged between the anchor and head.Attempts to obtain additional information have been made; however, no more is available.

Event Description

Investigation completed.

Manufacturer Narrative

Investigation results were made available.Concomitant medical products according d11: item: sidus stem-free shoulder, humeral anchor, uncem.Catalog #: 01.04555.130 lot #: 2943298 item: sidus stem-free shoulder, head distractor catalog #: 01.04555.880 lot #: 4501661746.Dhr-review: ref:(b)(4).; lot:2946819 - yield:20 - delivered:20 the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Ref:(b)(4).; 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 disassamble the products.Therefore stronger hammer impactions on the distractor were applied it was finally possible to disassamble 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 paralel 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 gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2019-00638, 0009613350-2019-00639.

• Brand Name: SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 52-23
• Type of Device: SIDUS STEM-FREE SHOULDER
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8421030
• MDR Text Key: 138804864
• Report Number: 0009613350-2019-00135
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00889024415997
• UDI-Public: 00889024415997
• Combination Product (y/n): N
• PMA/PMN Number: K171858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• 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: 01.04555.525
• Device Lot Number: 2946819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 10/18/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 113