MAUDE Adverse Event Report: STRYKER CORP BOTH HIPS METAL ON PLASTIC COBALT 9.9; PROSTHESIS, HIP, SEMI CONSTRAINED METAL/POLYMER CEMENTED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Complaint, Ill-Defined (2331); Toxicity (2333)

Event Date 05/20/2004

Event Type  Injury  

Event Description

Parts used as refresher contained cobalt.As high as 9.9.Noticed at least one or two yrs before surgery.It¿s really unclear how long it had been high.Mine was metal of plastic.Please notice a problem with metal on plastic.I had bone deterioration and had to have a lot of gray tissues which was removed.Now have a heart problem.

• Brand Name: BOTH HIPS METAL ON PLASTIC COBALT 9.9
• Type of Device: PROSTHESIS, HIP, SEMI CONSTRAINED METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER CORP
• MDR Report Key: 8405659
• MDR Text Key: 138385112
• Report Number: MW5084781
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/08/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2018
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 66