MAUDE Adverse Event Report: ZIMMER, INC. ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/P

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please see reports: 0001822565 - 2017 - 06121, 0001822565 - 2017 - 06122.Concomitant medical products: p/n 00625006520 bone screw self-tapping 6.5 mm dia.20 mm length l/n 6307619, p/n 00223200400 tension retaining device l/n 62014237, p/n 00875705002 shell with multi holes porous 50 mm o.D.Size hh for use with hh liners l/n 62700761, p/n 00999601735 femoral body - revision - nitrided - porous cementless 12/14 neck taper standard 40 mm neck offset, l/n 62972326 p/n 00801803203 femoral head sterile product do not resterilize 12/14 taper l/n 62694670.It has not been reported the devices have been revised; the devices cannot be returned for evaluation at the time of this reporting.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Still implanted.

Event Description

It was reported patient had a hip arthroplasty two years ago and is experiencing symptoms of metallosis, pseudotumor, pain, debilitation, and trunnionosis.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.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: ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/P
• 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: 6824789
• MDR Text Key: 83831747
• Report Number: 0001822565-2017-06122
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK113296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• 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: 00999601735
• Device Lot Number: 62972326
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2015
• 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): Required Intervention