MAUDE Adverse Event Report: ZIMMER, INC. APR HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 04/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Implanted: unknown date in 1991.Concomitant product - unknown apr liner.No devices or photos of the devices were received; therefore, the condition of the components is unknown.Additionally, visual and dimensional evaluations could not be performed.The product number and the lot number were not provided; therefore, the manufacturing date, the device history records and the field age of the device could not be determined.There is insufficient information to perform a complaint history search.A definitive root cause could not be determined, as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2017-03216.

Event Description

It was reported that a patient underwent an initial total hip arthroplasty on an unknown date for an unknown reason.Subsequently, this patient was revised due to poly wear, and instability.No know adverse events were reported during the revision surgery.Attempts have been made and no further information has been reported.

Manufacturer Narrative

Concomitant medical products: total head, +5.0 mm neck do not use with 12/14 taper 32 mm diameter cat: 720505032 lot: 331272, unknown stem, unknown cup.Reported event was confirmed through operative notes received.Third party review of the x-ray noted the femoral head is dislocated lateral to the acetabulum, no fracture was noted.Possible reason for dislocation was noted as polyethylene wear.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Device history record was reviewed and no discrepancies were found.Review of complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: APR HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6564229
• MDR Text Key: 75063326
• Report Number: 0001822565-2017-03215
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 433532051
• Device Lot Number: 30498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2017
• Initial Date FDA Received: 05/12/2017
• Supplement Dates Manufacturer Received: 10/10/2017; 03/14/2018
• Supplement Dates FDA Received: 10/11/2017; 03/15/2018
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR