MAUDE Adverse Event Report: ZIMMER, INC. XLPE LINER STANDARD; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Metal Shedding Debris (1804)

Patient Problems Host-Tissue Reaction (1297); Fatigue (1849); Nausea (1970); Necrosis (1971); Pain (1994); Discomfort (2330); Sleep Dysfunction (2517); Limited Mobility Of The Implanted Joint (2671)

Event Date 04/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Implant date - unknown date in (b)(6) 2013.Explant date - unknown date in (b)(6) 2017.Concomitant product(s): unk, unknown trilogy cup.Unk, unknown head.Unk, unknown stem.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 06124, 0001822565 - 2017 - 06126, 0001822565 - 2017 - 06127.

Event Description

It was reported patient underwent a right hip arthroplasty on an unknown date.Subsequently, patient was revised on an unknown date due to discomfort, pain, nausea, fatigue, difficulty walking, difficulty sleeping, elevated metal ion levels, tissue and muscle necrosis, and pseudotumors.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow up report is being submitted to relay additional information.

Event Description

It was reported that a patient underwent a right initial total hip arthroplasty due to unknown reasons.After the initial procedure the patient developed pain, elevated metal ion levels, discomfort, and required a revision in her right hip.During the procedure it was noted that there was an abundance of cloudy purulent-appearing fluid under tension which was decompressed.There was also evidence of muscle and capsular necrosis involving more than 50% of the abductor muscle.The head was removed.The taper was examined and showed extensive evidence of corrosion in the form of blackened metallic debris.Necrotic tissue was removed from around the acetabulum.The liner was removed, and there was evidence of deformation of the backside where the liner was in contact with the central hole in the shell.The acetabular component (cup) was well fixed.The femoral (stem) was well fixed.The taper was cleaned.Attempts have been made and no further information is available at this time.

Manufacturer Narrative

Reported event was confirmed by review of the provided op notes and photographs.Intra -operative photos were received along with the operative notes.Visual inspection of the pictures confirm taper corrosion and presence of necrotic tissue which was debrided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of complaint history search for components could not be performed with the available product information 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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

No additional event information is available at the time of this report.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: XLPE LINER STANDARD
• 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: 6842827
• MDR Text Key: 84932262
• Report Number: 0001822565-2017-06125
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990135
• 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,Followup
• Report Date: 06/24/2020

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
• Device Catalogue Number: 00630505632
• Device Lot Number: 6234880
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 09/05/2017
• Supplement Dates Manufacturer Received: 09/06/2017; 01/22/2018; 02/12/2020; 06/15/2020
• Supplement Dates FDA Received: 10/03/2017; 01/23/2018; 02/24/2020; 06/25/2020
• 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: 60 YR
• Patient Weight: 102