MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SHELL; UNKNOWN HIP DEVICE

Catalog Number UNK_JR

Device Problems Mechanical Problem (1384); Malposition of Device (2616)

Patient Problems Inflammation (1932); Injury (2348); Joint Dislocation (2374); Reaction (2414)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding malposition of an unknown shell was reported.The event was confirmed based on clinician review of the medical records provided.Method & results: product evaluation and results: not performed as the device was not returned - it remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: cup malposition in excessively low inclination has contributed to impingement between stem neck and mdm cup liner causing an intraprosthetic dislocation with extensive secondary metallosis of soft tissues, all requiring revision surgery.Stem neck/cup rim impingement causes an overload condition because the normal soft tissue dampening of the endpoints in hip rom is replaced with a hard/hard contact between stem neck and cup rim to create an overload condition with peak loading/bending forces upon the stem neck and cup during every impingement ¿hit¿ with a great variety of potential adverse effects of which dislocation is just one adverse outcome.[.] -product history review: not performed as no lot information was provided.-complaint history review: not performed as no lot information was provided.Conclusions: no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that patient's right hip was revised due to instability.X-rays and intraoperative observation revealed that the 28mm cocr head dislocated from the adm/mdm poly insert, which disassociated from the mdm metal liner.As a result, the cocr head was articulating directly against the mdm metal liner with significant black tissue, black fluid, and metallosis reported.Devices were revised to a 40 e 0° liner and a 40mm biolox head with a +4 v40 taper sleeve.The shell and securfit j stem were not revised.Update: as per medical review, cup malposition in excessively low inclination has contributed to impingement between stem neck and mdm cup liner causing an intraprosthetic dislocation with extensive secondary metallosis of soft tissues, all requiring revision surgery.

• Brand Name: UNKNOWN SHELL
• Type of Device: UNKNOWN HIP DEVICE
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8233011
• MDR Text Key: 132596446
• Report Number: 0002249697-2019-00138
• Device Sequence Number: 1
• Product Code: JDI
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2019

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: No Information
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 01/10/2019
• 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