MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Reaction (2414)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: (b)(4).Concomitant medical products: 00771100740, femoral stem, lot # 62400760.Part # unk, cup, lot # unk.Part # unk, liner, lot # unk.Multiple mdr reports were filed for this event; please see associated reports: 0001822565-2018-07066.

Event Description

It was reported that approximately 4 years post implantation, the patient underwent a revision due to elevated chromium ion levels.Attempts have been made and no further information has been provided.

Event Description

Upon receipt of additional information, it has been determined this report is a duplicate of the event reported on 0002648920-2017-00512.The initial report was forwarded in error and should be voided.If additional information regarding this event is received, a supplemental report will be filed under 0002648920-2017-00512.

Manufacturer Narrative

Upon receipt of additional information, it has been determined this report is a duplicate of the event reported on 0002648920-2017-00512.The initial report was forwarded in error and should be voided.If additional information regarding this event is received, a supplemental report will be filed under 0002648920-2017-00512.

• Brand Name: FEMORAL HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 8200512
• MDR Text Key: 131537468
• Report Number: 0002648920-2018-00887
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

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: 00801803202
• Device Lot Number: 62332074
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 03/28/2019
• Supplement Dates FDA Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention