MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN AVENIR HIP STEM

Catalog Number UNKNOWN AVENIR HIP STEM

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The manufacturer did not receive x-rays, or other source documents for review.As no lot number was provided, the device history records could not be reviewed.An e-mail requesting additional information was sent on december 18, 2018.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.(b)(4).

Event Description

It was reported that a patient underwent hip arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision on an unknown day for an unknown reason.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: additional: if follow-up, what type.Correction: date of report, date rec¿d by mfr.Dhr review: the dhr check could not be performed as the lot number was not available.Trend analysis: no trend analysis could be performed as no specific event information is available.Event description: it was reported by the 411 group that a patient underwent hip arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision on an unknown day for an unknown reason.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: no product documentation was reviewed for investigation.Root cause analysis: neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implants were received; therefore the condition of the components is unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.In conclusion, due to significant lack of information, it is impossible to perform a meaningful root analysis of the complaint.However, all possible causes related to the issues reported are listed in rmw.Conclusion: no ref/lot info regarding the product was available.No medical data was received to confirm any event.In the absence of those crucial information it is impossible to make a meaningful analysis of the reported planned revision surgery due to unknown reasons.Based on the available information, the complaint could not be confirmed and no exact root cause could be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: UNKNOWN AVENIR HIP STEM
• Type of Device: UNKNOWN
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8188772
• MDR Text Key: 131129485
• Report Number: 0009613350-2018-01285
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN AVENIR HIP STEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other