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

Model Number N/A

Device Problems Difficult to Insert (1316); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Date 02/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical device - femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 12.5 standard offset # item 00771101200 lot 63532049.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 that during a hip surgery, the femoral head presented dimensional difference in the final assembly with stem compared to the test assembly with the head test.The surgery was completed with another femoral head.No further information is available.

Manufacturer Narrative

(b)(4).D4: (b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The complaint was not confirmed or device analysis indicated that the device met specification.Visual examination of the returned product identified that the device was in good condition and where measured had met print specification.A functional test showed that the head had properly seated on the sample device.This event cannot be confirmed.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.

Event Description

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

• Brand Name: CO CR 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: 8497537
• MDR Text Key: 141394323
• Report Number: 0002648920-2019-00258
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

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: 63665150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention