MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DURASUL, ALPHA INSERT, KK/32; ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.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.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 initial surgery the alpha durasul liner did not sit properly in the fitmore cup initially.It was removed and reinserted and the attempt failed again.Hence another liner was used to complete the procedure.The second liner could fit properly.

Event Description

Investigation result is available now.

Manufacturer Narrative

Event description: it was reported that the during initial surgery the alpha durasul liner did not seat properly in the fitmore cup initially.It was removed and reinserted, and the attempt was failed again.Hence another liner was used to complete the procedure.The second liner could assemble properly.Product evaluation: visual examination: the complained durasul alpha liner was returned for investigation.On the insert there are hardly any signs of attempts of fitting it in the shell.The pole pin is slightly damaged.On the anchoring and articulation side, some scratches can be observed.Based on the fading of the marking on the rim it can be assumed that the insert was autoclaved.See also pictures attached.Measurements: to ensure the durasul alpha inlay kk32 have correct dimensions the following was measured with a caliper: diameter 50.37 +0.05 -0.05 specification: max.50.42 mm; min.50.32 mm measured value: 50.39 +- 0.01 mm conclusion: the characteristic is within specification.4.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): no ncr with a potential correlation to the reported event was found.The appropriate surgical technique states: if the liner can still be rotated with low torque after tapping it lightly, this indicates nonconcentric positioning or the presence of soft tissue between liner and cup.If unsure, the seating can be checked using a raspatory.If no stable fixation could be achieved, a new liner must be used.If the polar peg is deformed, it will not be possible to anchor the liner correctly.5.Conclusion: it was reported that the during initial surgery the alpha durasul liner did not seat properly in the fitmore cup initially.It was removed and reinserted, and the attempt was failed again.Based on the investigation the reported event can be confirmed.The returned insert with size kk32 has been produced according specifications and their correct size can be confirmed.The slightly damaged pole pin indicates the surgeon had difficulties with centering the insert within the cup prior to impaction.This is a common complication also described in the applicable surgical technique which requires the use of a new liner.Nevertheless, an exact root cause could not be determined.The investigation did not identify a nonconformance or a complaint out of box (coob).

• Brand Name: DURASUL, ALPHA INSERT, KK/32
• Type of Device: ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10626473
• MDR Text Key: 209775234
• Report Number: 0009613350-2020-00446
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K013935
• 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: 01/22/2021

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.00013.411
• Device Lot Number: 3013589
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 95