MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BI-METRIC POR FMRL 9.0X200 RT; FEMORAL HIP STEM

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# unknown, unknown head, lot# unknown; item# unknown, unknown cup, lot# unknown; item# unknown, unknown liner, lot# unknown.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent total hip arthroplasty on an unknown date.Subsequently, patient was revised due to periprosthetic fracture.During revision, surgeon was replacing stem.Surgeon took stem out and prepared to use revision stem.Surgeon reamed, but implant just fell in.Surgeon opened next size and it fit perfectly.Attempts were made to obtain additional information; however, none was available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Visual inspection of the stem identified no visual damages on the product.Dimensional analysis of the stem was performed and identified it to be within the print specifications.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BI-METRIC POR FMRL 9.0X200 RT
• Type of Device: FEMORAL HIP STEM
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8290283
• MDR Text Key: 134513850
• Report Number: 0001825034-2019-00373
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K993438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 162340
• Device Lot Number: 786960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 97 YR