MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER TRIAL HUMERAL PE-INSERT, 36-0; N/A

Model Number N/A

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive the device for review but it was mentioned that it will be returned.X-rays or other source documents were not provided for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.Additional information was requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.Zimmer biomet's reference number of this file is (b)(4).

Event Description

It was reported that during a shoulder arthroplasty, the green 36 +0 trial bearing was used to ensure the correct bearing was opened and implanted.When removing the trial from the definitive stem (which had been cemented in) fragments of the plastic bearing trial fractured from the trial and had to be removed from the patient.No surgery delay has been reported.

Manufacturer Narrative

Additional:h2, h6.Correction: b4, g4, g7, h10.No trend considering the following event is identified: instrument fracture.Device history records (dhr): as no lot numbers were provided for the device, the device history records could not be reviewed.An e-mail requesting missing device data information was sent to the complainant, however no additional information is currently available.At zimmer gmbh all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer gmbh and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Event summary: it is reported that during a shoulder arthroplasty implanting a as revision stem (size 7 x 190), tm baseplate (15mm post) and glenosphere (36) the green 36 +0 trial bearing was used to ensure the correct bearing was opened and implanted.When removing the trial from the definitive stem (which had been cemented in) fragments of the plastic bearing trial fractured from the trial and had to be removed from the patient.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis; according to the information received the device location is unknown.Root cause analysis: root cause determination using rmw: - instrument breaks, deforms, diverge or parts remain in wound due to inadequate design for intended performance not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.- instrument breaks, deforms, diverge or parts remain in wound due to mechanical properties of material insufficient => possible, raw material certificate could not be reviewed, therefore cannot be excluded.- instrument cannot be used with the mating instrument or mating implant as intended due to failure of instrument mating condition => possible, if the instrument is not maintained well over time it can fail.- fracture of instrument due to degradation of material due to cleaning and sterilization => possible, if the instrument is not maintained well over time it can fail.- wear particles can get into the wound can cause foreign body reaction due to excessive wear particles generated by instrument interfaces during use => possible, deterioration in function as a result of repeated use could lead to failure.- instrument breaks, deforms, diverge or parts remain in wound due to inadequate design for intended performance not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.- instrument breaks, deforms, diverge or parts remain in wound due to surgeon or staff unfamiliar with instrument usage and handling => possible, deterioration in function as a result of repeated use could lead to failure.- damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling => possible, utilization by unqualified and/or untrained individuals could lead to failure.- instrument breaks or deforms due to off-label / abnormal-use => possible, abnormal use could lead to failure.Conclusion summary: according to the event the provisional insert fractured while being removed from the stem.Product was not received for the investigation.No photos were available, neither the lot number of the instrument.Possible reasons of the failure include insufficient mechanical properties of material, degradation of material due to cleaning and sterilization, deterioration in function as a result of repeated use, utilization by unqualified and/or untrained individuals and abnormal use.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer biomet considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: ANATOMICAL SHOULDER TRIAL HUMERAL PE-INSERT, 36-0
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7326695
• MDR Text Key: 101987372
• Report Number: 0009613350-2018-00331
• Device Sequence Number: 1
• Product Code: HWT
• 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
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.04239.700
• Other Device ID Number: 00889024287778
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1