MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_HOWMEDICA CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED\]

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 04/18/2020

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

This complaint is for the revision on (b)(6) 2006.Stryker italy received a letter from the lawyer of a patient underwent to a revision surgery of the cup with implant of howmedica femoral head and diam wright medical ((b)(6) 2006) and then to an additional explant procedure and surgical cleaning at (b)(6) hospital in (b)(6) on (b)(6) 2015.First surgery was done on (b)(6) 1999 in (b)(6) hospital with howmedica implant and ceramic insert.The lawyer of the patient bases his request of damage on the evaluation of a medical experts who raised the responsibility both of the hospital rizzoli and of the manufacturer for having used a device releasing metal ions.No details in the letter related to the products.The legal of the patient asks for the compensation for damages.Stryker italy legal dept.Has already asked broadspire if this could be a abg ii modular case, but the name of the patient is not included in their files.

• Brand Name: UNKNOWN_HOWMEDICA CUP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED\]
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10395752
• MDR Text Key: 202708173
• Report Number: 0002249697-2020-01645
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2020

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: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 YR