MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH VITALOCK SOLID-BACK SHELL 58MM; IMPLANT

Catalog Number 6302-2-058

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Discomfort (2330); Disability (2371)

Event Date 09/23/2002

Event Type  Injury  

Event Description

Maude event report no mw5039205 stated: (b)(6) 2014: "i was sitting on the couch and it just popped out and dislocated.It almost dislocated three times before, but it did not come all the way out.The first time.I was trying on new shoes, it made a pop noise.Which was very scary, with some pain.The second time, i was sitting and it did it again with pop or chunk feeling in my hip.The third time, i was also sitting, and it did the same thing.All of these happened between (b)(6) 2001.To the date of the first dislocation.My hip never felt right.I told the doctor and the physical therapist after the first dislocation, it seemed to dislocate regularly.It might take one month or four or five month for it to happen.Later on, it seemed to come out all the time.The doctor that put it in died six weeks after my surgery.The doctor at the hospital told me i needed to have reconstructive surgery, which i could not afford, no insurance.The only reason i am reporting this now is because a lawyer gave me your address or web-site.I have been calling lawyers every time i saw an add on tv about bad prosthesis, about eight years.They always told me, they weren't going back that far.If it was 2002 they were going to 2001.I am supposed to have surgery on my hip right now if we can find a doctor that accepts (b)(6) for payment.Still waiting.I am wheelchair bound now and life is extremely difficult now.'.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device remains implanted.

Manufacturer Narrative

An event regarding dislocation involving a vitalock solid-back shell 58mm was reported.The event was not confirmed.Method & results: the reported device was not returned for evaluation.A review of the provided records and event description was performed by a clinical consultant.The clinical consultant indicated that insufficient information was received for review and that " need xrays, operative reports, clinical history." a review of the device history records could not be performed as no lot id was received.A complaint history review could not be performed as no lot id was received.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, clinical history , x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Maude event report no mw5039205 stated: (b)(6)-2014: "i was sitting on the couch and it just popped out and dislocated.It almost dislocated three times before, but it did not come all the way out.The first time.I was trying on new shoes, it made a pop noise.Which was very scary, with some pain.The second time, i was sitting and it did it again with pop or chunk feeling in my hip.The third time, i was also sitting, and it did the same thing.All of these happened between (b)(6) 2001.To the date of the first dislocation.My hip never felt right.I told the doctor and the physical therapist after the first dislocation, it seemed to dislocate regularly.It might take one month or four or five month for it to happen.Later on, it seemed to come out all the time.The doctor that put it in died six weeks after my surgery.The doctor at the hospital told me i needed to have reconstructive surgery, which i could not afford, no insurance.The only reason i am reporting this now is because a lawyer gave me your address or web-site i have been calling lawyers every time i saw an add on tv about bad prosthesis, about eight years.They always told me, they weren't going back that far.If it was 2002 they were going to 2001.I am supposed to have surgery on my hip right now if we can find a doctor that accepts (b)(6) for payment.Still waiting.I am wheelchair bound, now and life is extremely difficult now.'.

• Brand Name: VITALOCK SOLID-BACK SHELL 58MM
• Type of Device: IMPLANT
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4745653
• MDR Text Key: 5709385
• Report Number: 0002249697-2015-01428
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2015

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: Lay User/Patient
• Device Catalogue Number: 6302-2-058
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 05/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2015
• 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): Other
• Patient Age: 47 YR