MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SIZE 54 STRYKER CONSTRAINED LINER; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number UNK_JR

Device Problems Material Erosion (1214); Fracture (1260); Naturally Worn (2988)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 01/28/2022

Event Type  Injury  

Event Description

It was reported that the patient's right hip was revised.Original patient complaint was pain.Intra-operatively, the following was noted: the femoral head wore through both the inner bipolar component and outer portion of the constrained liner.The head articulated against the shell, causing wear in the shell.The constrained liner was revised to another liner, the shell, head, and stem were retained.

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.Device not returned to the manufacturer.

Event Description

It was reported that the patient's right hip was revised.Original patient complaint was pain.Intra-operatively, the following was noted: the femoral head wore through both the inner bipolar component and outer portion of the constrained liner.The head articulated against the shell, causing wear in the shell.The constrained liner was revised to another liner, the shell, head, and stem were retained.Update 21-april-2022: explant images indicate that both the constrained liner and metal head were revised.Review of medical files by a clinical consultant indicated the presence of osteolysis.

Manufacturer Narrative

Reported event: an event regarding crack/fracture and wear involving an unknown liner was reported.The events were confirmed.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs indicated that the constrained liner is significantly damaged.There is a large hole in the uhr bipolar head component of the constrained liner caused by pieces of both polyethylene and metal that had fractured off.The fractured metal pieces are also shown.It appears that the outer polyethylene liner has also fractured and broken in more than one place.The devices are covered in blood and tissue.-clinician review: a review of the provided medical information by a clinical consultant indicated: "review of the ap and lateral x-rays demonstrate a cemented femoral stem and head articulating with a constrained acetabular liner.There is significant osteolysis of the greater trochanter and a proximal cerclage wire.Unfortunately from this limited information i can not confirm the reported findings of wear through or the revision.Similarly, i can not determine a definitive root cause for this event." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to wear and fracture of the constrained liner and wear of the shell allegedly caused by articulation against the metal head.No patient trauma events were reported.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs indicated that the constrained liner is significantly damaged.There is a large hole in the uhr bipolar head component of the constrained liner caused by pieces of both polyethylene and metal that had fractured off.The fractured metal pieces are also shown.It appears that the outer polyethylene liner has also fractured and broken in more than one place.The devices are covered in blood and tissue.A review of the provided x-ray images by a clinical consultant also indicated the presence of osteolysis but was unable to determine the root cause of the events.Further information such as return of the devices, pathology reports, additional pre- and post-operative x-rays and the primary/revision operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNKNOWN SIZE 54 STRYKER CONSTRAINED LINER
• Type of Device: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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: 13522096
• MDR Text Key: 285527560
• Report Number: 0002249697-2022-00235
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2022
• 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: 57 YR
• Patient Sex: Male