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

Model Number N/A

Device Problems Corroded (1131); Insufficient Information (3190)

Patient Problems Pain (1994); Local Reaction (2035); Thrombosis (2100); Complaint, Ill-Defined (2331)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event: 0001822565-2017-01980, 0001822565-2017-01983, 0001822565-2017-01986, 0001822565-2017-01989.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.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

Patient's legal counsel reported unknown claims.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Device history report review was unable to be performed as the lot number of the device involved in the event is unknown.Reported event was unable to be confirmed as part number / lot number of device involved in the incident was unknown.Root cause was unable to be determined.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.

Manufacturer Narrative

Reported event was confirmed by review of medical records provided.Clear fluid was encountered upon entering fascia that appeared like joint fluid the fluid was slightly turbid but did not resemble gross purulence.Some of the fluid was sent for culture analysis.The hip capsule had all been replaced by a white hypovascular dense scar-like tissue.This tissue while was not thin black did have the other appearances consistent with an adverse local reaction to metal debris with replacement of healthy muscle.Head was removed and then evidence of taper corrosion was found with black staining over the trunnion.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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

It was reported patient underwent a revision procedure approximately eight years post implantation due to corrosion of the taper and pain.Operative report noted clear fluid that appeared like joint fluid.Rind like tissue which was pulled off the posterior border of the greater trochanter had the appearances consistent with alr (advanced local reaction) to metal debris with replacement of healthy muscle.When the head was removed, there was evidence of taper corrosion with black staining over the trunnion.Attempts to obtain additional information have been made; however, no more is available.

Event Description

Revision operative report notes patient was found to have chronic hip pain following a total hip arthroplasty that was done in 2008.The patient developed a limp, and also had a large soft tissue mass, which caused a dvt in her left lower extremity.The patient also has diminished sensation in the anterior portion of her thigh and medial portions of her thigh consistent with a potential mass effect on her branches of her femoral nerve.

• Brand Name: UNKNOWN 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: 6453745
• MDR Text Key: 71528151
• Report Number: 0001822565-2017-01980
• Device Sequence Number: 1
• Product Code: LPH
• 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: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2018

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: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 04/03/2017
• Supplement Dates Manufacturer Received: 08/03/2017; 03/01/2018; 03/29/2018
• Supplement Dates FDA Received: 08/03/2017; 03/28/2018; 03/30/2018
• 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; Other; Required Intervention
• Patient Age: 61 YR