MAUDE Adverse Event Report: ZIMMER GMBH INVERSE/REVERSE SCREW SYSTEM, 4.5-33; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Catalog Number 01.04223.033

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Pain (1994); Injury (2348)

Event Date 01/24/2013

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (b)(4) winterthur legal department is well trained and passes all information concerning the case to our complaint handling department.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

A product liability claim was raised.It was reported that the patient was implanted an inverse/reverse screw system, 4.5-33 on the left side on (b)(6) 2012.The patient was revised on (b)(6) 2013 due to the glenosphere disassociating from the baseplate.Improper installation of the baseplate screws resulted in a gap between the baseplate and the glenoid.Such a gap resulted in the looseness, pain, unnecessary and extreme wear, disassociation of the glenosphere, and could only be addressed through revision surgery.

Manufacturer Narrative

The device manufacturing quality records indicate that the released components met all requirements to perform as intended.No trend identified.The compatibility check was performed and showed that the product combination was approved by zimmer.Review of incoming information: it is reported that the patient received a tsa at date (b)(6) 2012 and was revised on date (b)(6) 2013 due to glenosphere and reverse pe insert dislocation.Moreover, improper installation of the baseplate screws resulted in a gap between the baseplate and the glenoid.Only one x-ray dated (b)(6) 2012 has been returned.It seems that the glenosphere dislocated from the reverse pe liner (pe liner, attached to humeral stem dislocated cranially).It is impossible to determine if the component were correctly implanted due to very poor image quality.The screws are very difficult to see in the x-rays.No statement can be performed on their position.Surgical report dated (b)(6) 2013: diagnosis: revision of anterior superior disassociated glenosphere, revision of reverse pe liner.No screw revision performed.No statement about screw position in the report.No other documents were provided a technical investigation was not possible to perform, as the devices were not at hand for investigation.Possible causes for the reported event according to dfmea: line 5 : disassociation, loss of function, pain, material fretting -> due to connection strength is insufficient for intended use: liner to humeral cup; humeral cup to stem line 14 : disassociation, loss of function, pain, material fretting -> due to connection between humeral cup and humeral stem is not assembled correctly line 15 : disassociation, loss of function, pain, material fretting -> due to connection between humeral cup and humeral cup liner is not assembled correctly line 20 : disassociation, loss of function, pain -> due to locking strength of screw cap to baseplate, locking the screw position, is insufficient line 29 : disassociation, loss of function, pain -> due to disassociation of modular components due to insufficient connection strength: glenoid sphere to baseplate line 35 : screws may disassociate from baseplate, loss of function, pain -> due to surgeon neglects to attach locking caps for screws to baseplate line 36 : screws may disassociate from baseplate, loss of function, pain -> due to surgeon fails to correctly attach locking caps for screws to baseplate line 64 : disassociation, loss of function, pain -> due to taper surfaces are not protected from contamination during surgery (i.E.Surfaces are not clean of organic material) 2.Comparison to investigation results whether it is possible and justification: line 5 : possible -> no product received, no implantation report received, very poor x-rays quality, cannot be excluded.Moreover, it is reported that an improper installation of the baseplate screws resulted in a gap between the baseplate and the glenoid line 14 : not possible -> no corrosion reported, screws not revised line 15 : possible -> no product received, no implantation report received, very poor x-rays quality, cannot be excluded.Moreover, it is reported that an improper installation of the baseplate screws resulted in a gap between the baseplate and the glenoid line 20 : possible -> no product received, no implantation report received, very poor x-rays quality, cannot be excluded line 29 : possible -> no product received, no implantation report received, very poor x-rays quality, cannot be excluded line 35 : possible -> no product received, no implantation report received, very poor x-rays quality, cannot be excluded.Moreover, it is reported that an improper installation of the baseplate screws resulted in a gap between the baseplate and the glenoid line 36 : possible -> no product received, no implantation report received, very poor x-rays quality, cannot be excluded line 64 : not possible -> no infection, no contaminated material reported.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

Manufacturer Narrative

The case was reopened and assessed again, because the device was received and has been investigated.The outcome is as follows: trend analysis: no trend identified.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event description (event details, per) event summary: it is reported that the patient received a tsa at date (b)(6) 2012 and was revised on date (b)(6) 2013 due to glenosphere and reverse pe insert dislocation.Moreover, improper installation of the baseplate screws resulted in a gap between the baseplate and the glenoid.Review of received data only one x-ray dated (b)(6) 2012 has been returned.It seems that the glenosphere dislocated from the reverse pe liner (pe liner, attached to humeral stem dislocated cranially).It is impossible to determine if the component were correctly implanted due to very poor image quality.The screws are very difficult to see in the x-rays.No statement can be performed on their position.Surgical report dated (b)(6) 2013: diagnosis: revision of anterior superior disassociated glenosphere, revision of reverse pe liner.No statement about screw position in the report.Devices analysis visual examination: two screws (1x length 33 and 1x length 48) and two locking caps were received for investigation.The visual examination shows that all received components do not show any deformation or damage.There are some handling marks on the screw head of both screws visible.No other abnormality could be detected on the received devices.Review of product documentation: the compatibility check was performed from surgical technique and showed that the product combination was approved by zimmer biomet.Root cause analysis: root cause determination using dfmea.Disassociation, loss of function, pain, material fretting due to connection strength is insufficient for intended use: liner to humeral cup humeral cup to stem => possible: no implantation report received, very poor x-rays quality, cannot be excluded.Moreover, it is reported that an improper installation of the baseplate screws resulted in a gap between the baseplate and the glenoid.Disassociation, loss of function, pain, material fretting due to connection between humeral cup and humeral stem is not assembled correctly => possible: no implantation report received, very poor x-rays quality, cannot be excluded.Moreover, it is reported that an improper installation of the baseplate screws resulted in a gap between the baseplate and the glenoid.Disassociation, loss of function, pain, material fretting due to connection between humeral cup and humeral cup liner is not assembled correctly => possible: no implantation report received, very poor x-rays quality, cannot be excluded.Moreover, it is reported that an improper installation of the baseplate screws resulted in a gap between the baseplate and the glenoid.Disassociation, loss of function, pain due to locking strength of screw cap to baseplate, locking the screw position, is insufficient => possible: no implantation report received, very poor x-rays quality, cannot be excluded.Disassociation, loss of function, pain due to disassociation of modular components due to insufficient connection strength: glenoid sphere to baseplate => possible: no implantation report received, very poor x-rays quality, cannot be excluded.Screws may disassociate from baseplate, loss of function, pain due to surgeon neglects to attach locking caps for screws to baseplate => possible: no implantation report received, very poor x-rays quality, cannot be excluded.Moreover, it is reported that an improper installation of the baseplate screws resulted in a gap between the baseplate and the glenoid screws may disassociate from baseplate, loss of function, pain due to surgeon fails to correctly attach locking caps for screws to baseplate => possible: no implantation report received, very poor x-rays quality, cannot be excluded.Disassociation, loss of function, pain due to taper surfaces are not protected from contamination during surgery (i.E.Surfaces are not clean of organic material) => not possible: no infection, no contaminated material reported.Conclusion summary: it was reported that the patient was revised on (b)(6) 2013 due to glenosphere and reverse pe insert dislocation.Two screws of different length and two locking caps were received for investigation.The visual examination did not show any abnormality of the received components.The implantation report has not been received.No detailed x-rays with high quality have been received.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: INVERSE/REVERSE SCREW SYSTEM, 4.5-33
• Type of Device: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580-0708 ; 8006136131
• MDR Report Key: 5322161
• MDR Text Key: 34247255
• Report Number: 9613350-2015-02091
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 01.04223.033
• Device Lot Number: 2656649
• Other Device ID Number: 00889024483033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR