MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN LEFT HIP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994); Injury (2348); Ambulation Difficulties (2544)

Event Date 06/09/2020

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

It was reported by the patient that he had a left tha done in 2015.In (b)(6) of 2020 while taking out the trash, the patient bent over to pick up some liter and collapsed.The patient couldn't move and was in excruciating pain.He also realized his left hip was higher than the right side.The patient could not move and he laid there for a while hoping someone or his wife would notice him.When he realized no one was coming he crawled and was able to get to the bumper of his car where his wife saw him and called emt.The patient was taken to the hospital where he had x-rays done and was told his hip was dislocated.The patient's hip was relocated and was told he had to follow up with his surgeon.The patient saw his surgeon a week later after the incident.While the patient was in his surgeon's office he was reading posters and when he turned to his right he felt the same excruciating pain.The surgeon reviewed the x-rays that were taking at the hospital and told the patient that the hip was not dislocated but broken.The emt was called and the patient was taken to the hospital.The following day the patient was revised.The patient had about 2 weeks of physical therapy after his revision.The patient is seeking compensation.

• Brand Name: UNKNOWN LEFT HIP
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10513128
• MDR Text Key: 206314308
• Report Number: 0002249697-2020-01826
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2020

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: 08/18/2020
• Initial Date FDA Received: 09/10/2020
• 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: 71 YR
• Patient Weight: 93