MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ZIMMER CONTINUUM HIGHLY CROSSLINKED POYLETHYLENE LINER; HIP, PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Rash (2033); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.The information provided on this form was previously submitted under manufacturing report number 0001822565-2016-04082.Device 4 of 5: reference mfr.Reports: 1822565-2014-00233, 1822565-2016-04081, 2648920-2016-03255 & 1822565-2016-04083.

Event Description

It is reported that a patient was experiencing a rash and high ion levels.

Manufacturer Narrative

No devices were received; therefore the condition of the components is unknown.Device history review for all related devices identified no deviations or anomalies.The devices were used for treatment.The reported components were reviewed for compatibility with no issues noted.A complaint history search for all related devices identified no additional complaints with the same part/lot number combinations.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.No photos or additional information was provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

• Brand Name: ZIMMER CONTINUUM HIGHLY CROSSLINKED POYLETHYLENE LINER
• Type of Device: HIP, PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6348670
• MDR Text Key: 67928204
• Report Number: 0002648920-2017-00064
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

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: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 00875101136
• Device Lot Number: 62172574
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2017
• Initial Date FDA Received: 02/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH
• Patient Outcome(s): Other
• Patient Weight: 77