MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN HEAD LFIT V40 +5MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNK_JR

Device Problems Degraded (1153); Detachment of Device or Device Component (2907); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032)

Event Date 08/18/2023

Event Type  Injury  

Event Description

Exact date no longer determinable by patient, he has had some pain for some time but did not pay much attention to it.He rested on a bench a few weeks ago after walking for a long time, did a few knee bends after getting up, then the patient suddenly heard a cracking sound and then almost couldn't walk anymore.Since then existing movement restriction and pain, can only walk short distances.Intraoperatively shows a conus dislocation with conus abrasion: after dissection of the gluteus minimus from the capsule, this opened.Black-greyish fluid discharged from the capsule as metal abrasion and a black membrane was seen.Implant was inserted in 2014.

Manufacturer Narrative

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

• Brand Name: UNKNOWN HEAD LFIT V40 +5MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17805304
• MDR Text Key: 324116438
• Report Number: 0002249697-2023-01065
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2023

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: 08/30/2023
• Initial Date FDA Received: 09/24/2023
• 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: 73 YR
• Patient Sex: Male