MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 105, TAPER 12/14; REVITAN STEMS

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 07/13/2021

Event Type  Injury  

Event Description

It was reported that during the surgery, when trying to separate the proximal neck from the distal shaft using a dismantling instrument, the threaded rod was seized and could no longer be turned or unscrewed.The entire stem including the instruments had to be removed and a new stem was implanted.

Manufacturer Narrative

This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.Associated devices: revitan, disassembly instrument; catalog#: 01.00409.801; lot#: 05.161079.Revitan, disassembly sleeve; catalog#: 01.00409.816; lot#: unknown.Revitan distal part, curved, uncemented, 18/140; catalog#: 01.00406.118; lot#: 3016562.Revitan proximal part, cylindrical, uncemented, 105, taper 12/14; catalog#: 01.00402.105; lot#: 3054979.Review of event description: it was reported that during the surgery on (b)(6) 2021, when trying to separate the proximal neck from the distal shaft using a dismantling instrument, the threaded rod was seized and could no longer be turned or unscrewed.The entire stem including the instruments had to be removed and a new stem was implanted.Review of received data: x-rays: the provided x-rays were reviewed but not sent for further analysis as the revision op notes were provided and have sufficient information.Surgical report: review of the provided surgical report identified the instruments and implant became stuck together during the attempt to remove the distal component from the proximal component.The surgeon then removes both the distal and proximal component together.It was reported that the customer followed the surgical technique.Product evaluation: visual examination: the visual examination confirms the reported event; it shows that the disassembly sleeve, disassembly instrument, threaded rod, and distal implant are all connected together.The devices could not be disassembled from one another using hand force.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Instruction for use (ifu): review of the ifu identified that the disassembly instrument and threaded rod can seize if the proper maintenance is not completed, which includes treated the threads of the instruments with lubricants.Surgical technique: review of the surgical technique identified that the threads of the threaded rod and disassembly instrument need to be treated with a lubricant after each cleaning.Conclusion: it was reported that during the surgery on (b)(6) 2021, when trying to separate the proximal neck from the distal shaft using a dismantling instrument, the threaded rod was seized and could no longer be turned or unscrewed.The entire stem including the instruments had to be removed and a new stem was implanted.Based on the investigation the reported event can be confirmed.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).It was noted that previously the surgical technique was updated for the curved and straight revitan stems to include more clear information regarding the necessity of lubricating the threaded rod and disassembly instrument after the devices are cleaned.This information is also communicated in the ifu and that lack of lubrication can lead to the threaded rod and disassembly instrument seizing.However, it was noted that the surgeon followed the surgical technique.As such, we are 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 biomet's reference number of this file is (b)(4).

• Brand Name: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 105, TAPER 12/14
• Type of Device: REVITAN STEMS
• 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: 12907974
• MDR Text Key: 281503379
• Report Number: 0009613350-2021-00625
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• 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
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.00402.105
• Device Lot Number: 3054979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 80 KG