DEPUY ASR ACETABULAR CUP SZ 56MM M277950

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-25 for DEPUY ASR ACETABULAR CUP SZ 56MM M277950 manufactured by Depuy Orthopaedics, Inc.

Event Text Entries

[21261774] I had a left total hip replacement on (b)(6) 2009. I received the depuy asr total hip system acetabular cup sz mm56 on the left hip. Prior to surgery, i had pain in my left hip due to degenerative joint disease. On (b)(6) 2011, i noticed a clicking noise in my left hip with pain. On (b)(6) 2012, i had to have a hip revision of my left hip. On (b)(6) 2012 and (b)(6) 2012, i suffered dislocation of my hip and had to have add'l hospitalization to have it put back into place.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5028797
• MDR Report Key: 2941338
• Date Received: 2013-01-25
• Date of Report: 2013-01-25
• Date Added to Maude: 2013-02-05
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: DEPUY ASR ACETABULAR CUP SZ 56MM
• Generic Name: METAL-ON-METAL HIP IMPLANT
• Product Code: KWA
• Date Received: 2013-01-25
• Model Number: M277950
• Catalog Number: M277950
• Lot Number: 2642704
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEPUY ORTHOPAEDICS, INC

Device Sequence Number: 2

• Brand Name: 49MM FEMORAL UNI DEPUY ASR SIZE 4 TRILOCK
• Generic Name: FEMORAL STEM
• Product Code: KWA
• Date Received: 2013-01-25
• Model Number: M277950
• Lot Number: 2779623
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: DEPUY ORTHOPAEDICS, INC

Device Sequence Number: 3

• Brand Name: ADAPTOR TAPER SLEEVE 12/14 +5
• Generic Name: FEMORAL HEAD
• Product Code: KWA
• Date Received: 2013-01-25
• Model Number: M277950
• Lot Number: 2746677
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: DEPUY ORTHOPAEDICS, INC

Device Sequence Number: 4

• Brand Name: ZIMMER 60 TRABECULAR METAL AND MULTIHOLE SHELL
• Generic Name: SHELL
• Product Code: JDI
• Date Received: 2013-01-25
• Device Availability: N
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: ZIMMER

Device Sequence Number: 5

• Brand Name: ZIMMER SCREW
• Generic Name: SCREW
• Product Code: HWC
• Date Received: 2013-01-25
• Device Availability: N
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: ZIMMER

Device Sequence Number: 6

• Brand Name: ZIMMER SCREW
• Generic Name: SCREW
• Product Code: HWC
• Date Received: 2013-01-25
• Device Availability: N
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: ZIMMER

Device Sequence Number: 7

• Brand Name: ZIMMER SCREW
• Generic Name: SCREW
• Product Code: HWC
• Date Received: 2013-01-25
• Device Availability: N
• Device Sequence No: 7
• Device Event Key: 0
• Manufacturer: ZIMMER

Device Sequence Number: 8

• Brand Name: ZIMMER 60X36 10 DEGREE POSTERIOR LIP LONGEVITY LINER
• Generic Name: LINER
• Product Code: LZO
• Date Received: 2013-01-25
• Device Availability: N
• Device Sequence No: 8
• Device Event Key: 0
• Manufacturer: ZIMMER

Device Sequence Number: 9

• Brand Name: FEMORAL HEAD AND NECK
• Generic Name: HEAD AND NECK
• Product Code: JDD
• Date Received: 2013-01-25
• Device Availability: N
• Device Sequence No: 9
• Device Event Key: 0
• Manufacturer: ZIMMER

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit	2013-01-25