MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/L FEMORAL STEM NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Host-Tissue Reaction (1297); Ossification (1428); Tissue Damage (2104)

Event Date 08/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: liner 10 degree elevated rim, pn 00631005836 ln 61149227.Femoral head sterile product do not resterilize 12/14 taper, pn 00801803602, ln 61185302.Tm modular acetabular shell, pn 00620205822, ln 61185302.Bone screw, pn 00625006520, ln 61160965.Bone screw, pn 00625006525, ln 61189894.Mdrs: 0001822565-2019-04649, 0002648920-2018-00658-2.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 mdr will be submitted.

Event Description

It was reported that a patient underwent an initial hip arthroplasty/ subsequently.The patient was revised approximately 9 years after the initial surgery due to in-vivo corrosion, heterotopic ossification, pseudocapsule/pseudotumor, tissue damage, elevated metal ion levels, and liner wear.During the revision procedure, it was noted that there was dehiscence of the posterior pseudocapsule with joint fluid communicating with trochanteric region.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Medical records were evaluated and the reported event was confirmed.Product was not returned.Reported event was confirmed by review of medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient underwent initial right tha and no complications were found.8 years post implantation, blood tests revealed elevated levels of cobalt 4.2 and chromium 1.2.Grade i heterotopic ossification and dehiscence of posterior pseudocapsule with joint fluid communicating with trochanteric region were noted.Discoloration was noted at the head-neck junction, femoral trunnion was completely discolored, consistent with fretting corrosion.The locking ring was freely moving and liner exhibited some wear.Patient was revised the head and liner were replaced.Device history record (dhr) was reviewed and no discrepancies were found.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.

Event Description

No further event information available at the time of this report.

• Brand Name: M/L FEMORAL STEM NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9265524
• MDR Text Key: 164581221
• Report Number: 0001822565-2019-04648
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K032726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00771101000
• Device Lot Number: 61118315
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR