MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DURASUL, ALPHA INSERT, GG/32; INTER-OP DURASUL ACETAB INSE/COCR FEMOR

Model Number N/A

Device Problems Use of Device Problem (1670); Compatibility Problem (2960)

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

Event Date 01/03/2022

Event Type  malfunction  

Manufacturer Narrative

Medical product: allofit alloclassic shl 48/gg; catalog#: 4243; lot#: 3065267, fitmore, hip stem, uncemented, b/5, taper 12/14; catalog#: 01.00551.205; lot#: 3064594, illegible biolox delta ceramic femoral head, illegible durasul alpha insert.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 surgery, after inserting the allofit acetabulum, carefully visualising the rims and correctly seating the plug, it was not possible to insert a durasul cup.The surgeron made three attempts, then was forced to use a new durasul cup which sat immediately and firmly in the acetabulum.

Manufacturer Narrative

Product has been received by zimmer biomet and the investigation has been completed.Investigation and conclusion: reported event: during surgery, after inserting the allofit acetabulum, carefully visualizing the rims and correctly seating the plug, it was not possible to insert a durasul gg/32 cup.The surgeon made three attempts, then was forced to use a new durasul gg/32, which sat immediately and firmly in the acetabulum.Patient involved.No delay.Harm: s1 - no patient, user, or other stakeholder harm.Hazardous situation: implant breaks or becomes damaged and non-functional during surgical procedure, but is replaced intraoperatively before completing implantation.Product evaluation: visual examination: only the durasul liner was returned for investigation.The visual examination shows that the liner has scratches, nicks and indentations on the surface.It has a deformed and indented pole peg, as well as deformations.In addition, there are pin imprints visible.The articulation surface has some scratches, but are otherwise inconspicuous.Review surgical technique: 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.In such situation, remove the liner, clean both surfaces and introduce the liner back into the shell, making sure it is properly centered and repeat the seating procedure.No further due diligence required as all required information to support the conclusion is available or was already requested.Devices are used for treatment.The product combination was approved by zimmer biomet.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination related to the event.Medical records were not provided.The quality records (dhr) 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).In conclusion, it can be assumed that the insert was in a slightly tilted position within the shell prior or during impaction leading to the assembly issue.However, based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

This follow-up report is being submitted to relay additional information.Investigation has been completed.

• Brand Name: DURASUL, ALPHA INSERT, GG/32
• Type of Device: INTER-OP DURASUL ACETAB INSE/COCR FEMOR
• 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: 13384822
• MDR Text Key: 284623620
• Report Number: 0009613350-2022-00046
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K993259
• 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: 04/20/2022

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 Model Number: N/A
• Device Catalogue Number: 01.00013.407
• Device Lot Number: 3060645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 01/28/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2021
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Sex: Female