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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Joint Dislocation (2374)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: name: humeral head 40-14, item#: 0104555400, lot#: 2716925.Name: a.S.Glenoid s cemented, item#: 0104214340, lot#: 2824234.Surgical reports were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.An e-mail requesting the following additional information was sent on august 16, 2019 to the appropriate representatives.The availability of the affected product(s) (non-availability with a rationale) all available x-rays during time in- vivo with printed date were there any contributing conditions related to the event? (ex: trauma, illness, related non-compliance, patient anatomy) was the surgical technique for the product utilized? 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 Description

It was reported that the patient was revised due to loosening with possible migration of the sidus anchor in the bone.

Event Description

Please refer to report 0009613350-2019-00501.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.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

No event update.

Manufacturer Narrative

Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.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 this item number.Result: issue evaluation request is not required.Lot specific investigation: less than 3 similar investigated events for the same lot number have been found.Result: issue evaluation request is not required.Review of event description: it was reported that the patient was implanted on (b)(6) 2016 and revised on (b)(6) 2018 due to loosening with possible migration of the sidus anchor in the bone.Review of received data: different x-ray views from different dates were received: (b)(6) 2016, (b)(6) 2018, (b)(6) 2019.Only the x-rays within the time in vivo are considered for the review.The images dated (b)(6) 2018 are a series of ct images which doesn't allow a clear evaluation due to the brightness of the head on the images.When comparing the pictures taken on (b)(6) 2016 and (b)(6) 2018 some minor changes to the bone can be seen in the region of the humeral anchor.Radiolucent line around the cranial fins can be seen on the x-ray from (b)(6) 2018 compared to the preliminary x-ray from (b)(6) 2016.A change in the implant position is not visible.However, the x-ray views of the two dates are not exactly the same (bone and / or implant position) therefore the evaluation is only limited.The initial and revision surgery note were assessed and the findings can be summarized as follows: implantation surgery, (b)(6) 2016: indication for shoulder prosthesis is given by massive pain and increased arthrosis.The report describes the procedure according to the surgical technique.No complications are noted.Revision surgery, (b)(6) 2018: indication for revision was given by increasing pain, loosening of the component visible in spect-ct, no suspected infection.As the pain increased and the rotator cuff is still intact, the indication is given to change the stem alone.It is described that the sidus component, which is loose, is removed without additional bone loss.Then the new components are implanted.No complications are noted.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.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.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 patient was implanted on (b)(6) 2016 and revised on (b)(6) 2018 due to loosening with possible migration of the sidus anchor in the bone.The initial and revision surgery note were assessed and no complications are noted.In the revision surgery note it is described that the sidus component was found loose.Radiologically, possible indications of loosening of the humeral head can be seen.No product was returned to zimmer biomet for in-depth analysis.Review of product documentation showed that the product combination was approved by zimmer biomet.Further, 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).However, based on the available information, we were not able to identify an exact root cause for this issue.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 ANCHOR, UNCEMENTED, L
• 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: 8900451
• MDR Text Key: 154527398
• Report Number: 0009613350-2019-00501
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 00889024397187
• UDI-Public: 00889024397187
• Combination Product (y/n): N
• PMA/PMN Number: K171858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.04555.120
• Device Lot Number: 2833839
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 08/29/2019; 02/27/2020
• Supplement Dates FDA Received: 09/18/2019; 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR