MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DURASUL, ALPHA INSERT, HOODED, KK/32

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned 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 the surgery the durasul alpha insert could not be inserted into the cup.Despite several attempts, the insert could not be inserted into the cup to make it hold.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that during surgery, the durasul alpha insert could not be inserted into the cup.Despite several attempts, the insert could not be inserted into the cup to make it hold.Surgery was completed with another new inlay.Product evaluation: visual examination: the complained durasul alpha liner was returned for investigation.Articulation side: the rim shows some scratches and imprints from the liner setting instrument.Further, on the articulation surface some scratches and nicks can be seen.Backside: the centralizing liner pole pin is cut off.Signs of attempts of fitting the insert in the shell can be seen in the form of indented lines and scratches across the anchoring side.Based on the visual examination the reported event can be confirmed.Measurements: to ensure the durasul alpha inlay hooded kk/32 have correct dimensions, relevant characteristics according to inspection plan were measured with caliper rüegger.Characteristic no.3 feature (diameter 50.37 mm +/- 0.05).Specification: max.50.42 mm; min.50.32 mm.Measured value: 50.39 +/- 0.02 mm.Conclusion: the characteristic is within specification.Review of product documentation: device purpose: this device is intended for treatment.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.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 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.) (note: if unsure, the seating can be checked using a raspatory.If the fitting of the liner is faulty, a new insert must be used.If the polar peg is deformed, it will not be possible to anchor the liner correctly.) conclusion: it was reported that during surgery, the durasul alpha insert could not be inserted into the cup.Despite several attempts, the insert could not be inserted into the cup to make it hold.Surgery was completed with another new inlay.Based on the investigation the reported event can be confirmed.The detected damages / imperfections on the returned insert indicate that the liner was mispositioned, nonconcentric or interfered with soft tissue residues.It is possible that remains of tissue and/or inappropriate alignment of the inlays prior or during impaction prevented the inlays from snapping into position.Further, cutting off the pole pin of the inlays is considered an off-label use, as the durasul alpha inlay must not be altered in any way.The pole pin is an essential design feature for centralizing and stabilizing the inlay inside the allofit shell.Nevertheless, based on the investigation and the available information, we were not able to identify an exact root cause for the reported assembly issue.However, this is a common complication also described in the applicable surgical technique of the allofit acetabular system.This complication requires the use of a new liner, which has been applied correctly.The investigation did not identify a nonconformance or a complaint out of box (coob).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, HOODED, KK/32
• Type of Device: DURASUL, ALPHA INSERT, HOODED, KK/32
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10626482
• MDR Text Key: 209773880
• Report Number: 0009613350-2020-00447
• Device Sequence Number: 1
• Product Code: KWB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• 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: 01.00013.511
• Device Lot Number: 3022327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization