MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM MOD HD +3MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Host-Tissue Reaction (1297); Tissue Damage (2104); Osteopenia/ Osteoporosis (2651)

Event Date 07/21/2020

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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03690.

Event Description

It was reported by patients legal counsel the patient underwent a left hip revision approximately 14 years post implantation of the acetabular cup, femoral head, and an orif of the acetabular posterior column with an excision of excessive soft tissue tumor/metallosis as well as primary repair gluteus medius muscle avulsion.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records were provided and reviewed.Review of the operative notes confirms that the patient underwent primary left hip arthroplasty.No complications noted during the procedure.Review of revision operative notes confirms that the patient underwent revision left hip arthroplasty approximately 14 years later.Left revision of acetabular cup, femoral head, orif of acetabular posterior column, excision of excessive soft tissue tumor/metallosis, primary repair gluteus medius muscle avulsion, increased serum metal ions.Significant metallosis encountered, large bursa w/ fluid and metal stained tissues underlying the fascial layer.Femoral head removed.Large granulomatous layer which was excised nothing that the gluteus medius had avulsed after the anterior third to half of the greater trochanter.Used explant system to excise cup without significant bone loss.Noted posterior column was deficient and there was a gap of appx 4cm from 1 o¿clock position to appx 3-1/2 to 4o¿clock position.No underlying bone support to place a dome shaped acetabular augment.Cup impacted at 20 degrees of anteversion and 45 degrees abduction.Stability was tested, rigid press-fit although inferior ischio aspect had some mobility.Multiple screws used to fixate cup to pubis as well as superior dome and anterior column.Bone grafted pubic area with cancellous bone chips.Posterior column also required reconstruction.A small frag t plate placed into the superior dome and contoured along posterior aspect of cup fixating it to remaining ischial bone to stabilize column.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 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, b5, d4, d9, g3, h2.

Event Description

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

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.One m2a 1 pc shell 38mmx50mm and one m2a 38mm mod hd +3mm nk were returned and evaluated.Upon visual inspection both of the returned devices have debris attached with no visible damage.Device history record (dhr) was reviewed and no discrepancies were found.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.

• Brand Name: M2A 38MM MOD HD +3MM NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10778375
• MDR Text Key: 214527187
• Report Number: 0001822565-2020-03692
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2022

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 Expiration Date: 04/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 11-173663
• Device Lot Number: 310440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/11/2020; 02/09/2022; 03/16/2022
• Supplement Dates FDA Received: 11/12/2020; 02/15/2022; 03/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN STEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female