MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SIDUS HEAD

Model Number N/A

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994); Arthralgia (2355)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer received other source of documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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

Patient was implanted on the right side and experienced pain.It was suspected that the cause of the pain may be due to the sidus-head being too big or because of infection.Hence patient underwent revision surgery during which a smaller head was implanted and the patient was treated with antibiotics.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional information which received on mar 11, 2021.Additional: b5, b7, correction: b4, d8, g3, g6, h2, h10.The manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the right side and experienced pain.It was suspected that the cause of the pain may be due to the sidus-head being too big.Hence patient underwent a revision surgery during which a smaller head was implanted.Patient underwent second revision surgery during which sidus and anaverse implants were replaced.Notification date confirmed to be the (b)(6) 2021.

Event Description

Investigation has been completed.

Manufacturer Narrative

Investigation results were made available.Additional: h2, h6.Correction: b4, b5, g3, g6, h10.Event description: it was reported that the patient underwent primary implantation of an anatomical anaverse glenoid system and sidus stem-free system on (b)(6) 2019 and experienced pain, possibly due to the sidus humeral head being too big or because of infection.A revision surgery was carried out on (b)(6) 2020, whereby a smaller humeral head was implanted and the patient was treated with antibiotics.On (b)(6) 2020, it was noticed that there is no more indication of infection, but the anaverse pe liner was loose.A subsequent revision surgery was carried out on (b)(6) 2021.Both the anaverse and sidus system were revised and a competitor product was implanted.Review of received data: - no medical records relevant to the case have been received.However, despite no lab report being received, an e-mail received from the sales rep on (b)(6) 2021 states that infection could be confirmed.Also, several notes of the primary implantation report (dated (b)(6) 2019) were provided within the e-mail.This includes the indication for implantation being arthritis, no bone grafts being used during implantation, no bone defects being noted and the condition of the rotator cuff as being functional.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: document review for the sidus humeral head and sidus anchor could not be performed due to unknown product identification.Device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records for the known products identified no deviations or anomalies during manufacturing.Sterilization certificate: single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards.The irradiation certificate of the known affected lot numbers have been reviewed and were found to be according to specification.Conclusion: it was reported that the patient underwent primary implantation of an anatomical anaverse glenoid system and sidus stem-free system on (b)(6) 2019 and experienced pain, possibly due to the sidus humeral head being too big or because of infection.A revision surgery was carried out on (b)(6) 2020, whereby a smaller humeral head was implanted and the patient was treated with antibiotics.On (b)(6) 2020, it was noticed that there is no more indication of infection, but the anaverse pe liner was loose.A subsequent revision surgery was carried out on (b)(6) 2021.Both the anaverse and sidus system were revised and a competitor product was implanted.It was reported that infection could be confirmed.The investigation did not identify a nonconformance or a complaint out of box (coob).Review of the device history records for the known products identified no deviations or anomalies during manufacturing with a potential correlation to the reported event.Sterilization certifications were reviewed and found to be conforming with no applicable deviations.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards.The irradiation certificate of the known affected lot numbers have been reviewed and were found to be according to specification.The reported event of the humeral head potentially being too big may or may not have caused or contributed to the patient experiencing pain post-implantation.Neither any additional information in regards to this event nor any device identification for the humeral components have been received.It is also not known if the sensation of pain was resolved after a smaller humeral head was implanted in the revision surgery dated (b)(6) 2020.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for the infection and event of pain possibly related to the humeral head size.An infection can have numerous root causes.These may include multiple factors that are outside the control of zimmer biomet, such as hospital/surgical environment, and/or patient history.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).Note: same patient underwent another surgery covered in: (b)(4).The following reports are associated with this event: 0009613350-2021-00054-2.

• Brand Name: SIDUS HEAD
• Type of Device: SIDUS HEAD
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11271053
• MDR Text Key: 230011562
• Report Number: 0009613350-2021-00060
• Device Sequence Number: 1
• Product Code: PKC
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2021

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 03/11/2021; 06/18/2021
• Supplement Dates FDA Received: 03/22/2021; 07/16/2021
• 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: 53 YR