MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 5.5/127 DEGREE ACCOLADE TMZF PLUS STEM; HIP IMPLANT

Catalog Number UNK_SHC

Device Problems Positioning Problem (3009); Noise, Audible (3273)

Patient Problems Injury (2348); Reaction (2414)

Event Date 05/07/2007

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported through a research article: a (b)(6) man who had undergone staged bilateral tha presented with squeaking of the right hip while walking.Symptoms had been present for 2 months and had progressed to a sensation of clunking one week prior to the office visit.The tha on the right side was done 6 years ago and examination showed no shortening or neurovascular deficit.The patient had normal range of motion with an audible clunk that was not associated with pain.He was not playing any sports and denied any injury.His weight, height, and body mass index were (b)(6), respectively.Radiographs showed a relative change of alignment between the head and neck compared with previous radiographs.The change was subtle and not appreciated on an initial radiograph obtained when the patient was seen by a midlevel provider.A month later, when the patient was seen by the operating surgeon, the findings were more obvious.Laboratory studies showed a normal erythrocyte sedimentation rate and c-reactive protein level.

• Brand Name: UNKNOWN 5.5/127 DEGREE ACCOLADE TMZF PLUS STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6285961
• MDR Text Key: 66031663
• Report Number: 0002249697-2017-00298
• Device Sequence Number: 1
• Product Code: MEH
• 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: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2016
• 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: 72 YR
• Patient Weight: 83