MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 44-16

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Toxicity (2333); Arthralgia (2355); Joint Dislocation (2374); Metal Related Pathology (4530)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: baseplate, s, 15mm; item#0104440002; lot#2978786; dpsc screw, 39mm; item#0104440039; lot#2977730; dpsc screw, 24mm; item#0104440024; lot#2977735; sidus stem-free shoulder, humeral anchor, uncemented, m; item#0104555120; lot#2960618.The manufacturer received x-rays and other source documents which will be reviewed as part of ongoing investigation.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.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 underwent revision due to dislocation, wear and metallosis.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event summary: on (b)(6) 2019 a total anatomical shoulder endoprosthesis on the right side consisting of sidus stem-free shoulder on the humeral side and anaverse glenoid on the glenoid side was implanted.The initial course was without problems.In (b)(6) 2020 the patient experienced acute pain in the right shoulder without trauma during window cleaning.Radiographically, a dislocation of the liner was seen and therefore the indication for revision was given.Patient was converted to inverse configuration.Summary of retrieval analysis: the returned retrievals as well as the received medical documents were reviewed and investigated by the zimmer biomet research department.This outcome of the investigation can be summarized as follows: the x-rays at hand, taken on (b)(6) 2020, show at least partial contact between the humeral head and the baseplate.The audible crepitus when moving, intraoperative photos and the smearing on the articulation surface of the retrieved humeral head point to contact with the baseplate leading to metalosis.The intraoperative photos seem as well to document that the liner could be removed before dislocating the joint.Based on this it has to be assumed, that the anaverse glenoid liner was at least for a certain period before the revision surgery, performed on (b)(6) 2020, partially or completely disassociated.The phenomena seen on the retrieved liner can be summarized as scratches, signs of wear, abrasion and deformation.In addition the anchoring side exhibits a fracture of the posterior snap, a slightly deformed peg and a superiorly displaced indentation from the contour of the baseplate.Based on the received information and the investigation it is not possible to find out which phenomena occurred at what point in time (e.G.Before or after the disassociation) and why.It stays unknown if one or several of the mentioned phenomena could possibly have triggered the other or contributed to it, or are a concomitant of it.The reason(s) for the disassociation stays unknown.Review of product documentation: all involved devices are intended for treatment.Device history records (dhr) of liner: the quality records of the anaverse liner and sidus humeral head show that all specified characteristics have met the specifications valid at the time of production.The relevant dimensions of the liner (e.G dimensions and distance of snaps) of all (b)(4) manufactured parts of lot 2977479 were measured with the coordinate measuring machine (cmm, 3dmm6z) and found to be within the pre-defined tolerance range.Product compatibility: the product combination was approved by zimmer biomet.No further due diligence required as all required information to support the conclusion is available/was already requested.Summary: on (b)(6) 2019 a total anatomical shoulder endoprosthesis on the right side consisting of sidus stem-free shoulder on the humeral side and anaverse glenoid on the glenoid side was implanted.The initial course was without problems.In (b)(6) 2020 the patient experienced acute pain in the right shoulder without trauma during window cleaning.Radiographically, a dislocation of the liner was seen and therefore the indication for revision was given.On the basis of the retrieval analysis the reason(s) for the disassociation remains unknown.Further, the investigation results did not identify a non-conformance or a complaint out of box (coob).The quality records show that all specified characteristics have met the specifications valid at the time of production.It is assumed that the cause of the disassociation of the liner from the baseplate is multi-factorial.However, the exact root cause for this case cannot be determined based on the available information.A comprehensive root cause investigation is currently ongoing.As a precautionary measure it was decided in may 2020 to remove the anaverse glenoid liners from the market.In november 2020 a follow-up letter was sent in order to provide the current rate of post-operative disassociation, an update on the investigation, and additional information when treating patients who received this product.It is recommended to ensure regular follow-up with all patients who have the anaverse glenoid pe liner implanted.Within the investigation into the potential causes of the pe liner disassociation, zimmer gmbh has decided to assess potential design updates pertaining to the locking feature(s) that are intended to enhance stability between the pe liner and the baseplate.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 HEAD, 44-16
• Type of Device: SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 44-16
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10425225
• MDR Text Key: 203500078
• Report Number: 0009613350-2020-00384
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 00889024415935
• UDI-Public: 00889024415935
• 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
• Report Date: 03/15/2021

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: 01.04555.440
• Device Lot Number: 2956512
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention