MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unequal Limb Length (4534)

Event Date 10/09/2021

Event Type  Injury  

Event Description

A journal article was retrieved from arthroplasty (2021) that reported a study from (b)(6).The aims of this single center study are to review the mid-term outcomes of porous tantalum cups (tm) and evaluate complications.The data were collected from 2006 to 2018.A total of 59 acetabular revisions in 58 patients were performed using an uncemented tm acetabular component (trabecular metal¿ zimmer biomet) by a single surgeon.Additional screws were used as necessary.Augments were used in two revisions.The head and a constrained liner were also placed.Four patients were lost to follow-up and 13 died during the period without having further surgeries attributed to hip arthroplasty.The remaining 41 patients (42 joints) who underwent revision hip arthroplasty had complete data available.Aseptic loosening (60.3%) of the cup was one of the main indications for the revision surgery, followed by femoral aseptic loosening (11.8%), fracture (11.8%), cup-malalignment (8.8%), infection (3.3%) and metal-on-metal related pathology (4%).The study population had a mean age of 70.11 years at time of surgery (range 30 to 87 years); 23 males, 36 females.Follow-up was conducted clinically and radiographically at six weeks, six months, and annually thereafter with a mean length of follow-up for 87 months (range 24-144 months).The study reported 3 patients had limb length issues less than 2cm, which were addressed by orthotics.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown zimmer biomet tm cup, unknown liner, unknown head.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The reported event was identified during review of a journal article: references bawale, r., choudhry, b., & samsani, s.(2021).Mid-term outcomes of tantalum cup- a single centre study.Arthroplasty (london, england), 3(1), 42.Https://doi.Org/10.1186/s42836-021-00099-z.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- stem reported event was unable to be confirmed due to limited information received from the customer.Device history record 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.

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14842905
• MDR Text Key: 295111667
• Report Number: 0001822565-2022-01902
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

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?: No
• Device Operator: Health Professional
• Device Model 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: 06/14/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 07/05/2022
• Supplement Dates FDA Received: 07/11/2022
• 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): Other