MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US G2 PRESS FIT STEM SZ8L; G2 CEMENTED AND CEMENTLESS STEMS : HIP FEMORAL STEM

Catalog Number 900000128

Device Problem Fracture (1260)

Patient Problems Fall (1848); Ambulation Difficulties (2544)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Hcp reported to nca (bfarm): patient reports to have fallen to the right side on normal walking, after his leg sagged.Afterwards he was not able to fully load the leg.Until this time walking distance was not limited.X-ray showed taper fracture of hip-stem.Condition after implantation of hip-prosthesis in 2003.Change of inlay (duraloc) and head (merete) after anamnetic inlay wear about three years ago.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : a review of the dhr has been completed and found this lot to be manufactured on january 28, 2003 with one deviation.This deviation(dev-1553), was for a shipping issue that was found previously.There is no correlation with the current complaint failure mode.

• Brand Name: G2 PRESS FIT STEM SZ8L
• Type of Device: G2 CEMENTED AND CEMENTLESS STEMS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11003972
• MDR Text Key: 221468847
• Report Number: 1818910-2020-26880
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K982812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2020

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: 900000128
• Device Lot Number: 1078996
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 12/21/2020; 03/08/2021
• Supplement Dates FDA Received: 01/11/2021; 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (MERETE); DURALOC SECTOR SERIES 62OD; ENDURON 10D 62 OR 74ODX28ID; G2 PRESS FIT STEM SZ8L; HIP BA BIO 28MM 12/14 + 5; (MERETE)
• Patient Outcome(s): Required Intervention