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

Model Number N/A

Device Problem Compatibility Problem (2960)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive devices for review.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.The actual device reported in section d is not marketed in usa, but devices with similar characteristics (i.E.) are marketed in usa, and therefore this report was filed.An e-mail requesting the following additional information was sent on july 17, 2017 to the responsible person who initiated this complaint: lot number.The availability of the affected product(s) (non-availability with a rationale).Exact event date.Did event happen during surgery? was the product implanted? was the surgery finished with a different device? surgical reports.All available x-rays during time in- vivo with printed date.All available intraoperative pictures.Patient dob, weight, height, bmi and all relevant history.Did a delay in the procedure over 30 minutes occur that was related to the event? were there any contributing conditions related to the event? (ex: trauma, illness, previous surgery, related non-compliance, patient anatomy).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.(b)(4).

Event Description

It was reported that the durasul, alpha insert, hh/32 did not fit as it had some dimensional issue.No further information is available at that time, it is unknown how the surgery was completed.No harm to patient has been reported.

Manufacturer Narrative

Additional information has been received and included in this report.The lot number was received for the device: the device history records were reviewed and found to be conforming.Zimmer lab received the device for investigation and investigation is ongoing.As soon as investigation result become available, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

Manufacturer Narrative

Investigation results were made available device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: assembly problem / does not fit review of event description: it was only reported that the durasul alpha insert, hh/32 did not fit as it had some dimensional issue.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 durasul alpha insert, hh/32 (ref.01.00013.408) was received for the investigation.No deformation at the articulating surface is visible.The anchoring surface of the insert exhibits scratches and multiple indents due to the contact with the shell spikes.Most indents are observed to be unpaired and not symmetrical along the pole plug axis.It indicates a difficulty in seating the insert inside the shell and multiple times of impaction.The centering peg of the insert is deformed and has scratches on the tip surface.Measurements: to ensure the insert has correct dimensions, the relevant characteristic according to the inspection plan were measured with and compared with the respective drawing.Characteristic no.16 feature "diameter" -specification: 44.69 +0.05/-0.05 mm -measured value: 44.69 mm measurement of the characteristics 31 and 38 are not taken into consideration since the pole plug of the liner was deformed during the operation.The conducted measurements confirm the correct size of the affected liner.Review of product documentation: - inspection plan (durasul alpha insert): - characteristic no.16 feature "diameter" by 100% qualitative inspection with gage, quantitative inspection aql 0.65, automated inspection aql 1.0.Means of inspection: 3d-messmaschine.- characteristic no.31 feature ¿distanz basisfläche zu polabschluss¿ by visual inspection aql 1.0, quantitative inspection aql 2.5 inspection.Means of inspection: 3d-messmaschine.- characteristic no.38 feature ¿zapfendurchmesser¿ by visual inspection aql 0.65, qualitative inspection aql 1.0, automated inspection 2.5.Means of inspection: caliper.- the surgical technique for allofit/allofit-s alloclassic acetabular system page 11-12 explains then correct procedure to position the durasul alpha insert.Root cause analysis: root cause determination using dfmea: - damage of the insert (cause: impaction during implantation) due to high load due to impaction during primary implantation or revision => possible: high load may lead to damage of the insert.- difficulties to assemble insert due to high load due to impaction during primary implantation or revision leading to damage of screw plug => possible: it is unknown if the screw plug is damaged, therefore cannot be excluded.- difficulties to assemble insert due to high load due to impaction during the primary implantation or revision leading to damage of the polar plug => possible: polar plug is damaged, therefore it is possible.- difficulties to assemble insert due to high load due to impaction during primary implantation or revision leading to damage of polar thread of shell => possible: the shell was not received for the investigation, therefore this risk cannot be excluded.- difficulties to assemble insert due to high load due to impaction during the primary implantation or revision leading to fracture of the pelvis => possible: it is unknown if the pelvis fractured, therefore cannot be excluded.- failure of connection between shell and insert due to wrong pairing of components (wrong size) => possible: pairing component is unknown, therefore cannot be excluded.- failure of connection between shell and insert (wrong pairing) due to wrong selection of parts due to unknown compatibility => possible: pairing component is unknown, therefore cannot be excluded.- failure of connection between shell and insert due to wrong assembly procedure => possible: damages (deformed peg on the insert, unpaired indents due to the two pins of the shell, scratches) indicate the insert was not centered correctly within the shell prior to impaction with the hammer.Conclusion summary: dhr review of the insert confirms that the product was manufactured according to the specifications.Moreover, the measurement of the received insert confirms the correct size.Nevertheless, possible causes for the reported failure include high load due to impaction during the primary implantation, wrong pairing of components (wrong size), 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).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: DURASUL, ALPHA INSERT, HH/32
• Type of Device: ALPHA DURASUL INSERTS
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6720639
• MDR Text Key: 80257656
• Report Number: 0009613350-2017-00980
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2017

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: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.00013.408
• Device Lot Number: 2895910
• Other Device ID Number: 00889024413603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2017
• Initial Date FDA Received: 07/18/2017
• Supplement Dates Manufacturer Received: 11/10/2017; 11/19/2017
• Supplement Dates FDA Received: 12/06/2017; 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• 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