MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. GTS STANDARD FEMORAL STEM SIZE +3; PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR

Catalog Number PS129GP3

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).List of associated devices: g7 bispherical shell 58g; ref#110017335; lot#6527436; g7 neutral e1 liner 36mm e; ref#010000857; lot#6524503; delta cer fm hd 036/0mm12/14 m 12/14; ref#650-0837; lot#2019071399.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was reported that patient had pain when bearing weight.In addition, it was reported that the cup could be involved.No medical treatment has been provided to patient.

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was reported that patient had pain when bearing weight.In addition, it was reported that the cup could be involved.As reported no medical treatment has been provided to patient.On (b)(6) 2021 medical records were received and investigations are still ongoing.

Event Description

It was reported that patient had pain when bearing weight.In addition, it was reported that the cup could be involved.No medical treatment has been provided to patient.X-rays were received and reviewed on (b)(6) 2021: while the quality of the x-rays is not good, there appears to be a lucency on the superior part of the cup, that could indicate inadequate fixation/bone on growth.However, the review of these x-rays has shown that the stem was well positioned.Thus, the reported event was not able to be recreated.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.As it was still implanted, the device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.X-rays were received and reviewed: while the quality of the x-rays is not good, there appears to be a lucency on the superior part of the cup, that could indicate inadequate fixation/bone on growth.However, the review of these x-rays has shown that the stem was well positioned.Thus, the reported event was not able to be recreated.A complaint extract was done regarding medical: pain: 4 complaints (4 products), this one included, have been recorded on gts standard femoral stem size +3, reference ps129gp3, from 01-jan-2018 to 26-mar-2021.1 complaint (1 product), this one included, has been recorded on gts standard femoral stem size +3, reference ps129gp3, batch 0001263706, since ever.According to available data, root cause of the event was unable to be determined.However, there is no evidence that the event is related to the product.The complaint is closed but could be reopened if new information is received later.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: GTS STANDARD FEMORAL STEM SIZE +3
• Type of Device: PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 11391276
• MDR Text Key: 233950259
• Report Number: 3006946279-2021-00021
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2021

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: Lay User/Patient
• Device Expiration Date: 11/19/2022
• Device Catalogue Number: PS129GP3
• Device Lot Number: 0001263706
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 03/16/2021; 04/09/2021
• Supplement Dates FDA Received: 03/31/2021; 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASSOCIATED DEVICES LISTED IN H10.
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 84