MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. GTS STANDARD FEMORAL STEM SIZE -2

Catalog Number PS129GM2

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 06/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).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.

Event Description

It has been reported that a patient underwent an initial hip procedure on (b)(6) 2014.Subsequently, the patient was revised due to pain on (b)(6) 2015.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated :b5, d5, g1-2, g4, h2, h3, h6, h10.H3 - the device was not evaluated as the batch number was not communicated and the product was not returned.The device was not returned to the manufacturer.Therefore it could not be analyzed.The product remained implanted and was not analysed.The device manufacturing quality record could not been reviewed as the item and lot number of the product were not communicated.3 similar complaints have been recorded mentioning an issue with psoas on gts femoral stems (all references) products since one year.With the available information, the exact root cause of the event could not 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.H3 other text : batch number not communicated.

Event Description

It was reported that the patient underwent an initial hip procedure on (b)(6) 2014.Subsequently, the patient suffered pain.Firstly, the patient received analgesic and anti-inflammatory treatment.Then the patient was revised on (b)(6) 2015 to remove the exceed stop screw and perform a psoas tendon tenotomy.During this procedure both implants were perfectly stable and without any abnormality.

• Brand Name: GTS STANDARD FEMORAL STEM SIZE -2
• Type of Device: NA
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8349578
• MDR Text Key: 136473987
• Report Number: 3006946279-2019-00125
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03599870096765
• UDI-Public: (01)03599870096765
• 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
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

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 Catalogue Number: PS129GM2
• Device Lot Number: NOT COMMUNICATED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 09/02/2019
• Supplement Dates FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: EXCEED CUP SIZE 50.; EXCEED POLYETHYLENE INSERT SIZE.; EXCEED SCREW TITANE.; HEAD CERAMIC SIZE 32.; EXCEED CUP SIZE 50; EXCEED POLYETHYLENE INSERT SIZE; EXCEED SCREW TITANE; HEAD CERAMIC SIZE 32
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 78