MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK E 12/14 NECK TAPER USE WITH +0 HEADS ONLY; PROSTHESIS, HIP

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Tissue Damage (2104); Blood Loss (2597); No Information (3190)

Event Date 05/13/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) concomitant medical products: item #: unknown, unknown head, lot #: unknown.Item #: unknown, unknown liner, lot #: unknown.Item #: unknown, unknown cup, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.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 - 00567, head.

Event Description

It was reported that the patient underwent a revision procedure approximately 6 years post-implantation due to unknown reasons.Attempts were made to obtain additional information; however, none was available.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records showed end stage oa of left hip.End stage collapse of the femoral head with numerous cysts in the acetabulum.Patient underwent some second-degree heart block intraoperatively and in the post operative recovery room.Preoperatively, 40 degree flexion contracture noted.Postoperatively, could extend to 10 degrees short of full extension.Op notes were provided for a revision procedure due to pain and gluteus medius tear.Gluteus medius and tendon did have viable muscle.The cup was noted radiographically to not be completely medialized, however it was not noted by the revision surgeon to be malpositioned given the complications from the initial surgery.Given patients symptoms, the cup could be further medialized which may alleviate patient¿s lateral pressure and allow for healing of the repair.Metal testing showed levels of chromium, at 1.1, and cobalt, at <1.0, that did not exceed 3.0ng/ml.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 that the patient underwent a left hip arthroplasty.The patient underwent a head and neck revision procedure approximately 6 years post-implantation due to pain and tissue damage with gluteus medius tear.Cup found not completely medialized.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).D11: versys femoral head +0 (00-8018-036-02, 61199493), tm modular acetabular shell (00-6202-056-22, 61193387), trilogy acetabular liner (00-6305-056-36, 61188255), m/l taper stem with kinectiv technology (00-7713-012-00, 61084440).

• Brand Name: MODULAR NECK E 12/14 NECK TAPER USE WITH +0 HEADS ONLY
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9717491
• MDR Text Key: 183527329
• Report Number: 0001822565-2020-00569
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2020

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 Expiration Date: 06/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 00784801200
• Device Lot Number: 60987273
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 02/27/2020; 05/18/2020
• Supplement Dates FDA Received: 03/06/2020; 05/27/2020
• 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