MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN PE LINER; INTER-OP DURASUL ACETABULAR INSERTS (4MM)

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Date 08/18/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

Event Description

It was reported in a journal article that the patient received an unknown pe liner on an unknown date.According to the journal article the patient experienced a complication of hematoma on an unknown date.

Manufacturer Narrative

The reported product was not manufactured by zimmer (b)(4).The device was manufactured by zimmer inc.(b)(4).An initial report and an follow up report have already been submitted ((b)(4); mfr report number: 1822565-2015-01739).Therefore this case will be invalidated.(b)(4).

• Brand Name: UNKNOWN PE LINER
• Type of Device: INTER-OP DURASUL ACETABULAR INSERTS (4MM)
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur, 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 5076840
• MDR Text Key: 25735308
• Report Number: 9613350-2015-01267
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2015

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2015
• Initial Date FDA Received: 09/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other