MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN HIP SYSTEM; HIP IMPLANT

Catalog Number UNK_JR

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Cancer (3262); Unequal Limb Length (4534)

Event Date 08/25/2015

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

Patient's mother called and stated that her daughter broke her hip due to cancer.Patient's mother stated they did a right hip replacement on (b)(6) 2015.Patient's right leg is shorter, continuous pain, cant walk and is in a wheel chair and they removed the cancer from her hip, but cant do a revision until patient is in remission.

Manufacturer Narrative

Reported event: an event regarding limb length discrepancy and patient factors involving an unknown shell was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: not performed as product was not returned, the reported device remains implanted.  - clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: in this unfortunate patient who had a salvage oncologic right hip cemented in place on (b)(6) 2015 for a pathologic acetabular fracture with a large lytic lesion of bone and the use of bone cement and a metallic cage for acetabular reconstruction, the metastatic disease continued to progress.Less than two months post-operative the cage was noted to have migrated vertically, but the hip remained reduced and the right hip x-ray remained stable for the next four years.Lack of host bone support led to the inevitable early migration of the acetabular reconstruction.There is no evidence that any factors associated with implant manufacturing, materials or recall were responsible for this clinical situation or the persistent symptoms related to the unfortunate spinal and left hemipelvis progression of the metastatic disease in this patient.Product history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusions: the medical review concluded that the lack of host bone support led to the inevitable early migration of the acetabular reconstruction.There is no evidence that any factors associated with implant manufacturing, materials or recall were responsible for this clinical situation or the persistent symptoms related to the unfortunate spinal and left hemipelvis progression of the metastatic disease in this patient.It is noted that a recall query was made regarding the product reported in this event.As no catalog or lot information pertaining to the device was provided, it cannot be confirmed if the product reported in this complaint investigation was subject to a recall.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

Event Description

Patient's mother called and stated that her daughter broke her hip due to cancer.Patient's mother stated they did a right hip replacement on august 25, 2015.Patient's right leg is shorter, continuous pain, cant walk and is in a wheel chair and they removed the cancer from her hip, but cant do a revision until patient is in remission.

• Brand Name: UNKNOWN HIP SYSTEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7479437
• MDR Text Key: 107098347
• Report Number: 0002249697-2018-01299
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

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: 04/04/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 61