MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. GTS STANDARD FEMORAL STEM CEMENTLESS S+5; PROTHESIS, HIP

Catalog Number PS129GP5

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 06/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products : 32mm 12/14 taper femoral head +8 neck, ref:650-0885, batch: r3197838a/e1 standard poly liner f32, ref:010000850, batch: 3309825/g7 pps ltd acetabular shell 56f, 010000665, batch: 3568096.Report source, foreign - event occurred in (b)(6).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 had persistent hip pain and was diagnosed as bursitis trochanterica, after primary total hip prothesis (thp) on (b)(6) 2015.Treatment (b)(6) 2017 with injection for pain without effect.The event was resolved on (b)(6) 2018 (the next clinic visit).

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The product analysis can't be performed as the product was not returned.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.An investigation has been performed, consisting of a documentary review.Based on the available information, no root cause was determined.However, clinical investigator assessed that it is not uncommon for patients to have a bursitis trochanterica after a total hip prothesis, and this event could be related to the surgical procedure.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 has been reported that a patient had persistent hip pain and was diagnosed as bursitis trochanterica, after primary total hip prothesis (thp) on (b)(6) 2015.Treatment was performed on (b)(6) 2017 with injection for pain without effect.The event was resolved on (b)(6) 2018 (the next clinic visit).

• Brand Name: GTS STANDARD FEMORAL STEM CEMENTLESS S+5
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8243821
• MDR Text Key: 132923281
• Report Number: 3006946279-2019-00002
• Device Sequence Number: 1
• Product Code: LZO
• 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: 05/29/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2020
• Device Catalogue Number: PS129GP5
• Device Lot Number: 00J3489174
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 01/14/2019
• Supplement Dates Manufacturer Received: 05/28/2018
• Supplement Dates FDA Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 79