MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH D/M GRIP AND 2 2.0MM HOMOG CBL; IMPLANT

Catalog Number 6704-0-210

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 04/09/2012

Event Type  Injury  

Event Description

(b)(4): "volun (b)(4)-2014: hello, my name is (b)(6) and i had a hip revision on (b)(6) 2012 and that was the second one.I had a total in 2000, and a revision in 2001; all biomet.The (b)(6) 2012 still gives me pain to this day.Feels like it is going to give out on me.I have pain in the groin down the back of the left leg.I have difficulty walking, performing housework, bending, i can't lay on it, the wire and cable set are stryker, (b)(4), lot-37079201 and two doctors said the wire needs to come out but the biomet is (b)(4), lot 316860, biomet (b)(4), lot 525920, biomet (b)(4), lot -211480.This product has given me pain 365 days and some it wakes me up every night and i mean every night.Pain down the back of my left and there is a radiating pain that goes to my chest and the biomet from 2001 was a failure.This product needs to come out and this would be the fourth one.This product really needs to be recalled.The doctors think this problem may be from the device.You can contact me at (b)(6).Thank you very much, (b)(6).Reason for use: left hip revision due to failure of hardware.Left hip revision.

Manufacturer Narrative

The circumstances described in the maude report detail mostly competitor's devices.However, the patient did note the following: "the wire and cable set are stryker, (b)(4), lot-37079201 and two doctors said the wire needs to come out." should additional information become available, it will be submitted in a supplemental report upon completion of the investigation.

Manufacturer Narrative

Weight updated.An event regarding pain involving a dall miles plate was reported.The event was not confirmed.Device evaluation not performed as the reported device was not returned for evaluation.A medical review was performed and concluded.Both the primary and revision total hip arthroplasty components in this case are from biomet.The only stryker product is a dall-miles cable grip with two cables, which successfully repaired the trochanteric osteotomy at the revision surgery.A dhr review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.A complaint history review indicated there have been no other events for the reported lot.A medical review was performed and indicated that x-rays demonstrate the device remained stable and intact and is unlikely related to any symptoms in this patient.No further investigation is required at this time.

Event Description

(b)(4): "volun 15-jan-2014: hello, my name is (b)(6) and i had a hip revision on (b)(6) 2012 and that was the second one.I had a total in 2000, and a revision in 2001; all biomet.The (b)(6) 2012 still gives me pain to this day.Feels like it is going to give out on me.I have pain in the groin down the back of the left leg.I have difficulty walking, performing housework, bending, i can't lay on it, the wire and cable set are stryker, ref-(b)(4), lot-37079201 and two doctors said the wire needs to come out but the biomet is ref-(b)(4), lot 316860, biomet ref (b)(4), lot 525920, biomet ref (b)(4), lot -211480.This product has given me pain 365 days and some it wakes me up every night and i mean every night.Pain down the back of my left and there is a radiating pain that goes to my chest and the biomet from 2001 was a failure.This product needs to come out and this would be the fourth one.This product really needs to be recalled.The doctors think this problem may be from the device.You can contact me at (b)(6).Thank you very much, (b)(6).Reason for use: left hip revision due to failure of hardware.Left hip revision.

• Brand Name: D/M GRIP AND 2 2.0MM HOMOG CBL
• Type of Device: 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3692503
• MDR Text Key: 4303459
• Report Number: 0002249697-2014-00847
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 6704-0-210
• Device Lot Number: 37079201
• Other Device ID Number: STER. LOT 1106GCM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2011
• 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 Weight: 95