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

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 11/02/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products and therapy dates: exceed cup size 50, head ceramic size 28, exceed polyethylene insert size 28.Report source, foreign - event occurred in (b)(6).Device evaluated by mfr? 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 device manufacturing quality record could not be reviewed as lot number of the product was not communicated.With the available information, the exact root cause of the event could not be determined.Please note that the patient fall was mentioned as related to the implant failure in the event description.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 a patient underwent an initial hip procedure on (b)(6) 2013.Subsequently, the patient was revised due to femoral implant failure after fall on (b)(6) 2013.

Event Description

It was reported that a patient underwent an initial hip procedure with gts stem implantation on (b)(6) 2013.Subsequently, the patient was revised on (b)(6) 2013 due to gts stem failure after a fall of the patient.The gts stem was removed and replaced with a cemented stem.Details on the implant failure were not communicated, however x-rays before and after revision showed that the bone seemed fractured, and that the revision consisted of the implantation of a longer stem and femoral cerclages.The gts stem failure after fall was therefore assessed as revision due to bone fracture after fall.No additional patient consequence were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being filled to relay additional information.The following sections were updated: b5, d1, d2, g1-2, g4, h2, h3, h6, h10.D11 - concomitant medical products: head ceramic size 28, reference and batch number are not communicated.Exceed polyethylene insert size, reference and batch number are not communicated.Exceed cup size 50, reference and batch number are not communicated.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.However, x-rays have been received.X-rays review shows that the gts standard femoral stem size -2 is intact and patient bone seems fractured.The reported event of gts stem failure could not be confirmed.The review of the device manufacturing quality can't be performed as the product batch number was not communicated.4 similar complaints (including the current complaint) have been recorded regarding a "bone fracture" on gts femoral stems (all references) since one year.With the available information, the exact root cause of the event could not be determined.Please note that the patient fall was mentioned as related to the implant failure in the event description.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.

• Brand Name: GTS STANDARD FEMORAL STEM SIZE -2
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8353648
• MDR Text Key: 136627126
• Report Number: 3006946279-2019-00131
• Device Sequence Number: 1
• Product Code: OCG
• 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: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: PS129GM2
• Device Lot Number: NOT COMMUNICATED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 64