MAUDE Adverse Event Report: ZIMMER, INC. HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Tissue Damage (2104); Reaction (2414)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please see reports: 0002648920 -2017 -00503; 0002648920 -2017 -00518.Concomitant medical products: p/n 00625006520, bone scr 6.5x20 self-tap, l/n 60337998; p/n 00625006520, bone screw self-tapping 6.5 mm dia.20 mm length, l/n 60410711; p/n 00625006530, bone screw self-tapping 6.5 mm dia.30 mm length, l/n 60337998; p/n 00620005020, shell porous with holes 50 mm o.D., l/n 60365243; p/n 00801802805, femoral head sterile product do not resterilize 12/14 taper, l/n 60239270; p/n 65786201320, femoral stem fiber metal taper collarless 12/14 neck taper with calcicoatâ® ceramic coating size 13 standard body extended neck offset.L/n 60377827.It has not been indicated the device will be returned for evaluation at this time.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported that the patient was revised due to recurrent dislocation.During the procedure the surgeon noted metallosis, reaction, joint effusion, soft tissue inflammation and trunnionosis.As the locking ring on the shell had been compromised and was not moving the surgeon removed the whole shell.No further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event.Please see reports: 0001822565-2017-05457, 0002648920-2017-00503, 0002648920-2017-00518, 0001822565-2017-07521.Concomitant medical products: 12/14 cocr femoral head 28 mm +10.5 catalog#: 00801802805 lot#: 60239270.Trilogy acet shell 50 mm od multi catalog#: 00620005020 lot#: 60365243.Unknown liner catalog#: unk lot#: unk.Bone screw 6.5x30 self-tap catalog#: 00625006530 lot#: 60337998.Bone screw 6.5x30 self-tap catalog#: 00625006520 lot#: 60410711.Bone screw 6.5x30 self-tap catalog#: 00625006520 lot#: 60337998.(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation is being sent to the complainant.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: HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
• 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: 6803527
• MDR Text Key: 83011281
• Report Number: 0001822565-2017-05457
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK980711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 65786201320
• Device Lot Number: 60377827
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2005
• 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