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

Catalog Number 8018-40-03

Device Problem Contamination (1120)

Patient Problems Abscess (1690); Fever (1858); Bone Fracture(s) (1870); Pain (1994); Test Result (2695)

Event Date 08/23/2017

Event Type  malfunction  

Event Description

Excerpt from electronic medical record: "(b)(6) male who is status/post a right total hip replacement in 2009.He had development of progressive right hip pain despite having a well-fixed total hip replacement.His workup in 2014 demonstrated significant metallosis with high chromium levels.In (b)(6), he sustained a fall with a right intertrochanteric fracture that was minimally displaced.Additionally, he had developed a fracture of the ischium and of the anterior column of his right acetabulum.He had gone on to develop a nonunion and further displacement of his right trochanteric fracture.The hip remained reduced and stable.Over the course of the last week he had multiple emergency room evaluations for progressive right hip pain.In (b)(6), he was admitted through the emergency room with fevers and a large, edematous and painful right thigh and hip.Workup revealed an elevated white cell count of (b)(6).Ct scan revealed a very large complex periprosthetic abscess extending almost to the knee.Ct had demonstrated an ischial nonunion, as well as a healing anterior column fracture.He had a displaced trochanteric nonunion".

• Brand Name: ZIMMER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• Manufacturer (Section D): ZIMMER, INC.; 345 e main st; warsaw IN 46580
• MDR Report Key: 6935295
• MDR Text Key: 88862732
• Report Number: 6935295
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2017

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 Operator: No Information
• Device Expiration Date: 12/01/2018
• Device Catalogue Number: 8018-40-03
• Device Lot Number: 60932219
• Other Device ID Number: +H124008018040031/18090509322
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS
• Patient Age: 88 YR
• Patient Weight: 85