MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM REVISION ACETABULAR; IMPLANT

Catalog Number 509-02-70I

Device Problems Device Slipped (1584); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/21/2015

Event Type  Injury  

Manufacturer Narrative

Device description reported as unknown cup.At this time, it cannot be determined if these devices may have caused or contributed to the patient¿s experience.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Not returned to manufacturer.

Event Description

It was reported that surgeon revised patient's left hip due to pain.Radiographically cup appeared to be loose.Intra operatively no loosening was confirmed.

Manufacturer Narrative

The following product was added to the complaint after the initial medwatch was submitted.Cat.No.: 2080-0025 gap plate screws, lot code: mlnv0p.Cat.No.: 2080-0035 gap plate screws, lot code: mmnxpv.An event regarding loosening involving a tritanium shell was reported.The event was not confirmed.Conclusion: method & results: -device evaluation and results: not performed as the device was not returned for evaluation.-medical records received and evaluation: a medical consultant has indicated that "based upon the information available for review, no determination can be made regarding the cause of the apparent failure of bony ingrowth into the revision acetabular component in this young patient with inflammatory arthritis." -device history review: indicated that the specified lot was accepted into final stock with no reported discrepancies.-complaint history review: indicated that there have not been any other events for the specified lot.Conclusions: the exact cause of the reported loosening could not be determined based on the information available.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and additional information become available, this investigation will be reopened.

Event Description

It was reported that surgeon revised patient's left hip due to pain.Radiographically cup appeared to be loose.Intra operatively no loosening was confirmed.

• Brand Name: TRITANIUM REVISION ACETABULAR
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5010605
• MDR Text Key: 23268210
• Report Number: 0002249697-2015-02695
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 509-02-70I
• Device Lot Number: MMPXN9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2013
• 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): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 52