MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNIPOLAR HEAD, S, 60/-4, TAPER 12/14; HIP PROSTHESIS

Model Number N/A

Device Problems Manufacturing, Packaging or Shipping Problem (2975); No Apparent Adverse Event (3189)

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

Event Date 09/26/2021

Event Type  malfunction  

Event Description

It was reported that there was packaging damage.

Manufacturer Narrative

This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.The manufacturer did not receive x-rays, or 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).

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6 correction: b4, g3, g6, h10.Event description: it was reported that the inner packaging of the implant was open when the outer packaging was intact.Different product/different size had to be used to complete surgery (ref.: (b)(4) ¿ batch: 3057927).Review of received data: - due diligence: further due diligence to support the conclusion was completed.- images: five pictures were provided within the complaint.Review of the received pictures show an open outer packaging carton box.Inside the box the strip with patient stickers is visible where one sticker is missing.Further pictures show the outer blister with inner blister inside.Both tyvek sheets are attached to the respective blister just partially.Product evaluation: - visual examination: the visual examination shows an open outer packaging carton box.On the strip with patient stickers one sticker is missing.Both tyvek sheets are attached to the respective outer blister and inner blister just partially.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check could not be performed as only the complained product is known.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.- a complaint history search completed.No additional complaints were identified for the same or similar event.No additional complaints were identified.Conclusion: it was reported that the inner packaging of the implant was open when the outer packaging was intact.Different product/different size had to be used to complete surgery.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.During the process step of clean and pack the sealed packaging is inspected and no imperfections have been identified according to quality records.Further, no additional complaints were reported for the same product/lot combination and no further products of this lot are on stock.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

No change to previously reported event.

• Brand Name: UNIPOLAR HEAD, S, 60/-4, TAPER 12/14
• Type of Device: HIP PROSTHESIS
• 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: 12712267
• MDR Text Key: 282196814
• Report Number: 0009613350-2021-00548
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 12/09/2021

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 30.60.09
• Device Lot Number: 2947613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 12/08/2021
• Supplement Dates FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1