MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ALLOCLASSIC, SL STEM, UNCEMENTED, 1, TAPER 12/14; ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

Medical products: 3.2mmx30mm rnglc+ acet drl bit; catalog#: 31-323230; lot#: 721600.G7 screw 6.5mm x 50mm; catalog#: 010001003; lot#: 3559034.Truncated blade.Sharp instrument enclosed; catalog#: 00-7053-056-10; lot#: unknown.Full blade.Sharp instrument enclosed; catalog#: 00-7053-056-20; lot#: unknown.G7 osseoti 4 hole shell 60mm g 0mm g; catalog#: 110010248; lot#: 6859167.G7 dual mobility liner 46mm g; catalog#: 110024465; lot#: 951430.G7 screw 6.5mm x 30mm; catalog#: 010000999; lot#: 6503130.Bone screw self-tapping 6.5 mm dia.30 mm length; catalog#: 00625006530; lot#: j6795645.Bearing 28 mm i.D.46 mm o.D.Size g; catalog#: 110031013; lot#: 64782598.Biolox option, head, xl, 28/+7, taper 12/14; catalog#: 00-8777-028-04; lot#: 2978525.Femoral head non-skirted 12/14 taper; catalog#: 00-8018-028-14; lot#: 63237411.Therapy date: unknown.The manufacturer received x-rays and other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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 a surgery, despite numerous attempts made to resolve the femoral head-taper engagement discrepancy, the issue persisted.The surgeon decided to open the retained version of stem and a new femoral head for seating confirmation.There was about 10-15 minutes surgical delay for trouble shooting process.After investigation, it was reported that the same version of the stem and head cannot be mated.

Manufacturer Narrative

Investigation results were made available.Additional: h2, h6, d9.Correction: b4, b5, g3, g6, h10.Event description: it was reported that during surgery on mar 24, 2021, numerous attempts were made to resolve a femoral head / taper engagement discrepancy.Then the surgeon decided to open the retained version of stem and a new femoral head for seating confirmation.There was about 10-15 minutes surgical delay for trouble shooting process.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: the provided x-rays were reviewed but not sent for further analysis due to the poor image quality and it would not enhance the investigation.Product evaluation: visual examination: visual examination of the provided device identified nicks and scrapes on the porous coating, including a scuff which caused the material to appear discolored.Measurements: the overall length of the stem was measured to be conforming to specifications, confirming the identity of the stem.No further dimensional analysis was completed as the device undergoes 100% dimensional inspection during manufacturing.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Conclusion: it was reported that during surgery on mar 24, 2021, numerous attempts were made to resolve a femoral head / taper engagement discrepancy.Then the surgeon decided to open the retained version of stem and a new femoral head for seating confirmation.There was about 10-15 minutes surgical delay for trouble shooting process.Based on the investigation the reported event cannot 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).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 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: ALLOCLASSIC, SL STEM, UNCEMENTED, 1, TAPER 12/14
• Type of Device: ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 12428143
• MDR Text Key: 271448733
• Report Number: 0009613350-2021-00462
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024481091
• UDI-Public: 00889024481091
• Combination Product (y/n): N
• PMA/PMN Number: K030373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

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: 2841
• Device Lot Number: 2896770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/06/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 11/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR