MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ALLOFIT, IMPACTOR, STRAIGHT; HIP INSTRUMENT

Model Number N/A

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: continuum tm shell clust 54 jj; catalog#: 00-8757-054-01; lot#: 64844056.Biolox delta taper lnr jj/36; catalog#: 00-8775-011-36; lot#: 3068722.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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

It was reported that during a hip prosthesis implant by impacting the final implant the cup holder broke.The implant was incorrectly positioned and while trying to correctly position it the surgeon damaged it, which forced him to change the implants (cup and head).Test revealed elevated levels of ions.

Manufacturer Narrative

Investigation results were made available.Review of event description: it was reported that during surgery on (b)(6) 2021 the allofit impactor broke during impaction of the shell.The implant was positioned incorrectly.During the attempt to correct the position, the surgeon damaged the implant, leading to replacement of the shell and head.Review of received data: no medical data relevant to the case has been received.Due diligence: no further "due diligence" required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination: the allofit impactor and the biolox taper liner were sent in for examination.The thread of the allofit impactor has flattened threads.The biolox taper liner shows seating patterns on the rim and numerous light gray stripes.There are some metal smears on the articulation surface.Review of product documentation: device purpose: this device is intended for treatment.Dhr review: review of the device history records identified no relevant deviations or anomalies during manufacturing.Conclusion: it was reported that during surgery on (b)(6) 2021 the allofit impactor broke during impaction of the shell.The implant was positioned incorrectly.During the attempt to correct the position, the surgeon damaged the implant, leading to replacement of the shell and head.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).Visual inspection shows damage to the thread of the allofit impactor.Possible causes include the thread being screwed in at an angle.However, a specific root cause could not be determined.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

No event update.Investigation results are now available.

• Brand Name: ALLOFIT, IMPACTOR, STRAIGHT
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 13009038
• MDR Text Key: 285687660
• Report Number: 0009613350-2021-00667
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.00469.001
• Device Lot Number: 4502359918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 110 KG