MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. GTS STANDARD FMRL STEM SIZE +5; PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR

Catalog Number PS129GP5

Device Problem Mechanical Jam (2983)

Patient Problem Failure of Implant (1924)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: delta ceramic femoral head 036/-4mm 12/14; ref #: 650-0836; lot #: 2018071561, investigated in (b)(4).Report source, foreign - event occurred in (b)(6).The device manufacturing quality record indicates that the released product met all requirements to perform as intended.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.

Event Description

It was reported that on (b)(6) 2019, the patient was implanted with the gts standard femoral stem cementless s +5 and the biolox delta ceramic femoral head 036/-4mm 12/14.The patient was saturated, medicated, and placed in the supine position.The surgeon decided to change the head because it did not suit/fit with the length of the limbs.He tried to remove the head but the whole stem came out.It was not possible to separate the head and the stem, which get stuck together.So they explanted both products.The procedure was finished using another head and stem with the right length.The surgery was extended by 15 minutes, no patient adverse consequences have been reported.

Event Description

It was reported that on (b)(6) 2019, the patient was implanted with the gts standard femoral stem cementless s +5 and the biolox delta ceramic femoral head 036/-4mm 12/14.The patient was saturated, medicated, and placed in the supine position.The surgeon decided to change the head because it did not suit/fit with the length of the limbs.He tried to remove the head but the whole stem came out.It was not possible to separate the head and the stem, which get stuck together.So they explanted both products.The procedure was finished using another head and stem with the right length.The surgery was extended by 15 minutes.No patient adverse consequences have been reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products: delta ceramic femoral head 036/-4mm 12/14; ref #: 650-0836; lot #: 2018071561, investigated in (b)(4).The device was not returned to the manufacturer.Therefore, it could not be analyzed.The pictures provide show the labels of the product.The reported event could not be confirmed.The review of the device manufacturing quality record indicates that 10 products designation gts standard tige t + 5, reference ps129gp5, lot number raj6352197 were manufactured on 25 january 2019.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No other similar complaint was recorded for gts standard tige t + 5, reference ps129gp5, lot number raj6352197 on the reported event within one year.According to available data, the exact root cause can 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.

• Brand Name: GTS STANDARD FMRL STEM SIZE +5
• 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: 8844874
• MDR Text Key: 153127678
• Report Number: 3006946279-2019-00355
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• 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: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2023
• Device Catalogue Number: PS129GP5
• Device Lot Number: RAJ6352197
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 70 YR