MAUDE Adverse Event Report: ZIMMER GMBH SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 42-15

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states under 510(k) number k003801.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The manufacturer did not receive x-rays, or other source documents for review.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).The following report is associated with this event: 0009613350-2018-00624-1.

Event Description

It was reported that the patient had a revision surgery approximately four years post implantation due to implant failure.Attempts to obtain additional information have been made; however, no more is available.

Event Description

It was reported that patient underwent revision surgery due to dislocation, loosenong and infection.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional and corrected information are filled in the following fields: 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).

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Corrected information are filled in the following fields: adverse event problem: the codes submitted with this report reflecting the situation occurred.Please disregard the codes previously submitted.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: infection, loosening event description: it has been reported that the patient was implanted with sidus shoulder components on the left side on (b)(6) 2014 and underwent a revision surgery on (b)(6) 2018 due to discomfort and pain.Radiological indication for loosening and infection was given.Due to the infection a two-stage revision, debridement, jetlavage with lavasept, biopsy, punctures, implantation of cement spacer was performed.The subsequent surgery was planned 6 weeks from the first revision surgery.Review of received data: no medical records of the primary implantation have been received.Surgical report of revision surgery performed on (b)(6) 2018 has been received: implant date: (b)(6) 2018.Implant surgeon: dr.(b)(6).Implant facility: (b)(6).Implanted devices: anatomical shoulder, glenoid (ref: 01.04214.345, lot: 2734714).Sidus stem-free shoulder, humeral head (ref: 01.04555.420, lot: 2717010).Sidus stem-free shoulder, humeral anchor (ref: 01.04555.110 ; lot: 2643707).Diagnosis: septic loosening of the anatomic shoulder tep left.Surgical procedure: revision, debridement, implant removal, staging, implantation of spacers shoulder left.Indication: due to radiologically distinct tep loosening (prosthesis sidus, pi 2013) and increased discomfort of the patient the decision was made to remove the prosthesis.Based on the distinct indication of loosening and the high risk of infection a two-stage revision was chosen.Description of procedure: access through the previous deltopectoralis access.Difficult tissue preparation due to highly scarred tissue.The ssc can no longer be presented.Débridement of the infectious tissue.Luxation of the prosthesis.The head component including the short stem is removed completely.Multiple punctures and biopsy (mibi/histo).Extensive debridement as well as jetlavage with lavasept.Insertion of a anatomical preformed cement spacer without steinmann nale.Reposition of the spacer.Insertion of a drainage.Closure.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Ifu sidus stem-free shoulder: precautions page 6: "surveillance for new or recurrent infections should be continued as long as the device is in place." adverse effects page 6: "wound infections".Root cause analysis: root cause determination of the humeral head and the humeral anchor using sap dfmea: implant loosening / subsidence due to stress shielding leading to bone loss possible, as no x-rays have been received this cause cannot be excluded.Implant loosening / subsidence due to insufficient primary stability possible, as neither medical records of the primary implantation nor x-rays of the situation after the primary implantation have been received this cause cannot be excluded.Non-sterile devices used due to sterilization process failure not possible as the sterilization certificates of all implanted devices do not show any non-conformance.Biological contaminated device is implanted due to unsterile implant due to inadequate packaging, packaging failure or exceeded expiration date possible, as a packaging failure during transport, storage or handling may be possible.Contaminated device will be used due to the packaging became defective due to inadequate transportation condition possible, as a packaging failure triggered by inappropriate transport may be possible.Contaminated device will be used due to the packaging is defective due to inadequate storage condition by the surgeon/hcp possible, as inappropriate handling cannot be neglected.Contaminated device will be used due to unintended and uncareful handling of device possible, as inappropriate handling cannot be neglected.Contaminated device will be used due to explanted implant is used for new implantation surgery possible, as we do not have any medical records regarding the primary implantation this cause cannot be excluded, even though, it is very unlikely as this is a single use device.Conclusion: based on the surgical report of the revision surgery and the given information the complaint could be confirmed.According to the medical documentation the patient was implanted with a sidus system on the left side on (b)(6) 2014 and underwent a revision surgery on (b)(6) 2018 due to loosening and infection after 4 years in-vivo.Due to the infection a two-stage revision surgery with implantation of cement spacers was performed.After the first revision surgery a subsequent surgery was planned 6 weeks from the first surgery.The received surgical report covers the first revision surgery only.No medical records about the primary nor about the second revision surgery have been received.Based on the time frame between the implantation and the explantation of 4 years it can be characterized as a late infection.Therefore, most likely the infection was spreading from somewhere else within the body.A perioperative infection, which may occur within the first two years after implantation is very unlikely.The reported implant loosening may be traced back to the formation of a biofilm around the implants.The irradiation certificates of the affected lots have been reviewed and were found to be according to specification.Therefore, it can be excluded that an unsterile device caused the infection.Moreover, no trend on infection has been observed for those products.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.It is highly unlikely that a disadvantageous product design favoured or contributed to the infection.However, the appropriate ifus for endoprosthesis states that ¿early or late infections¿ are ¿possible consequences of an implant¿ and should be considered when implanting zimmer biomet devices.Nevertheless, possible causes of infection include wrong handling of the device due to wrong information, wrong resterilization procedures for sterile delivered parts or packaging failure during transportation.Further, late infection may also be triggered by haematogenous seeding of bacteria from somewhere else within the body.As only little information is available we were not able to identify a specific root cause for the reported infection and the implant loosening.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

It was reported that patient underwent two-stage revision surgery following augmentation of discomfort and pain due to septic loosening and infection.

• Brand Name: SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 42-15
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7637448
• MDR Text Key: 112301470
• Report Number: 0009613350-2018-00649
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: PN/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: 10/05/2018

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: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.04555.420
• Device Lot Number: 2717010
• Other Device ID Number: 00889024415928
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 09/13/2018; 09/13/2018
• Supplement Dates FDA Received: 09/20/2018; 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: GLENOID, ITEM# 01.04214.345, LOT# 2734714.; HUMERAL ANCHOR, ITEM# 01.04555.110, LOT# 2643707.; GLENOID, ITEM# 01.04214.345, LOT# 2734714; HUMERAL ANCHOR, ITEM# 01.04555.110, LOT# 2643707
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 120