MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER M/L TAPER FEMORAL STEM; HIP PROSTHESIS

Model Number N/A

Device Problem Corroded (1131)

Patient Problem Reaction (2414)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.The following could not be completed with the limited information provided.Date implanted - (b)(6) 2013.Concomitant medical products- 00630506240 liner 62377066 (b)(6) 2013.Concomitant medical products- 00625006530 bone screw self-tapping 62483518 (b)(6) 2013.Concomitant medical products - 00625006535 bone screw self-tapping 62483026 (b)(6) 2013.Concomitant medical products - 00620005222 shell porous with cluster holes 62461277 (b)(6) 2013.

Event Description

It was reported that a patient underwent an initial right hip procedure approximately 3 years ago.Subsequently, the patient was revised due to pseudo tumor, metallosis and fluid collection.Corrosion was noted on the trunnion of the stem.The head was removed and replaced; a poly liner was implanted.There were no complications or delays reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable as this device was not involved in the event.The initial report was submitted in error and should be voided.

• Brand Name: ZIMMER M/L TAPER FEMORAL STEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6215448
• MDR Text Key: 63626821
• Report Number: 0001822565-2016-04725
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2018

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: Physician
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 65771101100
• Device Lot Number: 62423203
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: 03/02/2018; 07/20/2018
• Supplement Dates FDA Received: 03/30/2018; 08/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 56