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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or 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.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

Patient was implanted on the right side and is being monitored due to pain, decreased range of motion, difficulty with adls.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: additional: b7 - d11 - h2 - h6.Correction: b4 - g4 - g7 - h10.D11 - medical products and therapy date detail of product: item # 0104555460.Item name sidus stem-free shoulder, humeral head, 46-16.Lot # 2700825.Dhr review: 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: pain / limited range of motion event description: patient was implanted with sidus implants on (b)(6) 2013 and reported continued pain at 1, 2, and 5 year visits with decreased range of motion and pain.Review of received data: crf study report is reviewed.No osteolysis, radiolucency, hypertrophy or heterotopic ossification were observed at humerus.On the visit dated (b)(6) 2018 pain and impingement is noted, while range of motion is lower than before.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all involved devices are intended for treatment.Conclusion: according the crf report the pain that the patient experienced had stopped 1 year post-op and beginned again according 5 year post-op visit.In the last visit also impingement and lower range of motion were noted.No x-rays or medical notes were received.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 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 Description

Please refer to the report 0009613350-2018-01283.

• Brand Name: SIDUS STEM-FREE SHOULDER HUMERAL ANCHOR, UNCEMENTED, L
• Type of Device: SIDUS STEM-FREE SHOULDER HUMERAL ANCHOR
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8183824
• MDR Text Key: 130981420
• Report Number: 0009613350-2018-01283
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 00889024397170
• UDI-Public: 00889024397170
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

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: Lay User/Patient
• Device Expiration Date: 01/28/2013
• Device Model Number: N/A
• Device Catalogue Number: 01.04555.130
• Device Lot Number: 2693801
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR