MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM E; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032)

Event Date 04/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 010000663-g7 pps ltd acet shell 52e- 6578868; 192008- echo por fmrl nc 8x120mm- 083280; 12-115120-cer bioloxd mod hd 36mm -3 nk-2986013.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 02027, 0001825034 - 2020 - 02029.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient complained of severe pain with activity and was diagnosed with left hip iliopsoas/flexor tendonitis, trochanteric bursitis, and abductor tendonitis 3 months¿ post implantation.No revision has been scheduled.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.The following sections were updated/corrected updated: g4; h2; h3; h6.Reported event was confirmed via review of medical records by a health care professional.Review of the available records identified the following: a study patient had a left total hip arthroplasty, subsequently, she complained of severe pain with activity and was diagnosed with left hip iliopsoas/flexor tendonitis, trochanteric bursitis, and abductor tendonitis.Pt had pre-op history of trochanteric bursitis, and initial expected slower recovery time due to other comorbidities and medications r/t anxiety and insomnia, therapy may have been missed/delayed due to covid-19.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot 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.

Event Description

No additional information on reported event.

Manufacturer Narrative

The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient continues to experience pain, difficulty with self-care, as well as problems with ambulation at the six month and one year follow-ups.Physical therapy pre-scribed.Outcome pending.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: G7 NEUTRAL E1 LINER 36MM E
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10082978
• MDR Text Key: 194468064
• Report Number: 0001825034-2020-02028
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000857
• Device Lot Number: 6592218
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 70