MAUDE Adverse Event Report: ZIMMER, INC. VERSYS HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 7843-12-08

Device Problems Break (1069); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Fibrosis (3167)

Event Date 04/04/2023

Event Type  Injury  

Event Description

Pt underwent removal of total hip prosthesis and insertion of temporary hip spacer (b)(6) 2013.Then revision of total hip arthroplasty performed on (b)(6) 2014 with insertion of zimmer versys hip system size 12.Pt presented to dr's office on (b)(6) 2023 with increased right hip pain x 1 week with unk injury.X-ray showed a break in femoral component of the prosthesis.Pt underwent revision with right tha(total hip arthroplasty) under the services of dr.North (b)(6) 2023.The proximal broken stem was obviously loose from the prior trochanteric osteotomy, stem removed.Md retracted prior osteotomy, which was not healed other than fibrous ingrowth.Distal portion of stem was also loose.

• Brand Name: VERSYS HIP SYSTEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 16854024
• MDR Text Key: 314465342
• Report Number: MW5117188
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/01/2023
• Device Model Number: 7843-12-08
• Device Catalogue Number: 00784301208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White