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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer received 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 surgery it was reported that the alpha pe inlay did not fit properly into the allofit cup.A new inlay was used to complete the procedure.Surgery was delayed by a couple of minutes.

Manufacturer Narrative

Additional information which was received on dec 8, 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received surgical report for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

During surgery it was reported that the alpha pe inlay did not fit properly into the allofit cup.A new inlay was used to complete the procedure.Surgery was delayed by a couple of minutes.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that the alpha pe inlay did not fit properly into the allofit cup.A new inlay was used to complete the procedure.Review of received data: no medical data relevant to the case has been received.Product evaluation: visual examination (see pictures attached): the insert was received for investigation.On the articulation side, very slight circular imprints around the placement holes deriving from the setting instrument can be observed.The articulation surface is inconspicious.The backside of the insert reveals 3 sets of non-centrical indentations of the shell's anti-rotation spikes indicating the different attemps.The pole pin is slightly deformed.Measurements: to ensure the durasul alpha inlay 32/kk have correct dimensions, relevant characteristics according to inspection plan were measured with caliper z 7568.Characteristic no.11 feature (diameter 50.37 +0.05/-0.05).Specification: max.50.42 mm; min.50.32 mm.Measured value: 50.39 mm.Characteristic no.15 feature (diameter 47.6 +0.3/-0.3).Specification: max.47.9 mm; min.47.3 mm.Measured value: 47.65 mm.Characteristic no.16 feature (diameter 50.69 +0.05/-0.05).Specification: max.50.74 mm; min.50.64 mm.Measured value: 50.65 mm.Charcteristic no.21 feature (height of inlay 18.5 +0.05/-0.05).Specification: max.18.55 mm; min.18.45 mm.Measured value: 18.51 mm.Conclusion: the measured characteristic of the snap are within specification.Pin: charcteristic no.51 feature (diameter 4.6 +0.01/-0.01).Specification: max.4.7 mm; min.4.5 mm.Measured value: 4.68 -4.73 mm.Charcteristic no.45 feature (height 4 +0.1/-0.1).Specification: max.4.1 mm; min.3.95 mm.Measured value: 3.72 mm.Conclusion: the measured characteristic of the pin are not all within specification which is due to the slight deformation of the pin.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Dhr / ncr review: review of the device history records identified the following deviations and/or anomalies: 3 pieces were scrapped due to a surface imperfections the ncr and dhr review showed that all released products met the specifications valid at the time of production.Surgical technique: (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.) (if unsure, the seating can be checked using a raspatory.If the fitting of the insert is faulty, a new insert must be used.If the polar peg is deformed, it will not be possible to anchor the insert correctly.) conclusion: it was reported that the alpha pe inlay did not fit properly into the allofit cup.A new inlay was used to complete the procedure.Based on the investigation the reported event can be confirmed.The slightly deformed pole pin and the multiple sets of indentations indicate that 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.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).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 switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation has been completed.

• 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: 10778708
• MDR Text Key: 216360009
• Report Number: 0009613350-2020-00523
• 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,Followup
• Report Date: 01/19/2021

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: 3029382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 12/08/2020; 12/24/2020
• Supplement Dates FDA Received: 12/15/2020; 01/19/2021
• 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: 34 YR
• Patient Weight: 65