MAUDE Adverse Event Report: ZIMMER GMBH RESURFACING DUROM METASUL HEAD

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: durom acetabular component; catalog no#: unknown; lot#: unknown.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.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

Patient was implanted resurfacing durom metasul head and experienced periprosthetic fracture.It is unknown whether revision took place.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Trend analysis: a complaint history review, including part and lot specific investigation, could not be performed as the item number is unknown.Event description: it was reported that the product mentioned in journal article was implanted on unknown date and there was a periprosthetic fracture after resurfacing.It is unknown whether revision took place.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: - this device is intended for treatment.- the compatibility check could not be performed as there is no item# reported.- dhr review could not be performed since no lot number was available.Conclusion: it was reported that the product mentioned in journal article was implanted on unknown date and there was a periprosthetic fracture after resurfacing.It is unknown whether revision took place.In vivo time of the device is unknown.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the available information, we were not able to identify an exact root cause for this issue.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).

Event Description

Please refer to report 0009613350-2020-00092.

• Brand Name: RESURFACING DUROM METASUL HEAD
• Type of Device: RESURFACING DUROM METASUL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9796581
• MDR Text Key: 182469983
• Report Number: 0009613350-2020-00092
• Device Sequence Number: 1
• Product Code: KXA
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization