MAUDE Adverse Event Report: ZIMMER GMBH DURASUL, ALPHA INSERT, GG/32; DURASUL ALPHA INSERT

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem No Code Available (3191)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device : no associated products reported.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device 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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

During surgery on an unknown side, the alpha insert popped out of the shell.The surgery was completed with another device.The implantation and explantation dates are left empty as the device involved in this complaint was intra operatively removed.Hence, no expiration date is captured, for the same reason.

Event Description

No change to previously reported event.

Manufacturer Narrative

Correction: date of report, concomitant medical products, date received by mfr, type of report, device evaluated by mfr, additional narrative.Additional: medical products & therapy dates, follow up type.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.No trend considering the following event is identified: assembly issue event summary: it was reported that during surgery, the inlay disenganged from the shell after 5 minutes.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: visual examination: the inlay has been returned for an investigation.It has a deformed peg and some scratches on the outer and inner surface.Additionally, there are scratches on the rim area.On the anchoring surface of the inlay there are only very light imprints of the spikes of the metallic shell.Additionally, these imprints seem to be not in same distance from the polar peg indicating a wrong alignment of the inlay within the shell.See pictures attached.Measurement: to ensure the insert has correct dimensions, relevant characteristic according to the inspection plan was measured with the caliper.Due to the deformation of the peg, further measurements could not be performed.Characteristic feature diameter.Specification: 42.69 +0.05/-0.05 mm.Measured value: 42.69mm.Conclusion: the outer diameter of the insert can be confirmed.Review of product documentation: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Surgical technique: liner insertion.The pole plug allows appropriate fitting with the polyethylene liner peg.Bone or soft tissue remnants must not overlap the edge of the titanium shell as they may prevent the insert from snapping into position.The shell edge must be free from any tissue and particular attention must be paid to the posterior inferior bony edge of the acetabulum.Clean and dry the inner surface of the shell, connect the liner to the setting instrument, position the liner over the entrance plane of the shell and rotate clockwise.The peg of the polyethylene liner must be inserted into the pole plug hole.Complete seating of the liner with a light hammer blow.If the liner can still be rotated after light impaction, this indicates mispositionning, nonconcentric, or soft tissues interference between the liner and the shell surfaces.Root cause analysis: root cause determination using rmw: intraoperative complications due to excessive assembly force , leading to wrong aligned inlays.Possible, imprints from the spike indicate a wrong alignment intraoperative complications due to lack of assembly force and/or unclean mating faces are used, leading to wrong aligned inlays or loss of instrument-implant connection.Possible, imprints from the spike indicate a wrong alignment.Moreover these imprint are very light which indicated that the impaction force might have been too low or the mating faces were unclean.Intraoperative complications due to wrong alignment of insert in shell: possible, imprints from the spike indicate a wrong alignment.Intraoperative complications due to wrong positioned insert in shell :possible, imprints from the spike indicate a wrong alignment.Intraoperative complications due to excessive impaction force :possible, excessive force could lead to a failure of the connection.Intraoperative complications due to excessive impaction force :possible, excessive force could lead to a failure of the connection.Intraoperative complications due to lack of adequate impaction force :possible, inadequate force could lead to a failure of the connection.The very light imprints indicate that the impaction force might have been too low.Conclusion summary: it was reported that during surgery, the inlay disenganged from the shell after 5 minutes.Review of the dhr of returned insert with size gg/32 indicates that the devices met all requirements to perform as intended.The performed measurement was found to be according to the specification.Possible causes for the reported failure include high or low load due to impaction during the primary implantation, wrong assembly procedure, slight deformation of the metallic shell due to the very hard bone conditions, soft tissue and/ or debris left between insert and cup prior to seating and storing.The insert in a rather cold place which might lead to a slight decrease of the outer diameter (material reduction).The imprints on the anchoring surface of the inlay coming from the metallic spikes of the shell are very light and asymmetric and the peg ist deformed.Therefore, the most likely root cause of the event is the wrong alignment of the inlay within the metallic shell combined with a too low impaction force.However, ased on the given information and the results of the investigation, an exact root cause could not be determined.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: DURASUL, ALPHA INSERT, GG/32
• Type of Device: DURASUL ALPHA INSERT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7662330
• MDR Text Key: 113397115
• Report Number: 0009613350-2018-00683
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: PK993259
• 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: 12/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.00013.407
• Device Lot Number: 2941740
• Other Device ID Number: 00889024413597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 07/04/2018
• Supplement Dates Manufacturer Received: 12/14/2018
• Supplement Dates FDA Received: 12/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ITEM# 4263, LOT# 2944614, ALLOFIT SHELL.