MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT

Catalog Number UNK_REC

Device Problems Degraded (1153); Device Slipped (1584); Unstable (1667); Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problems Discomfort (2330); Ambulation Difficulties (2544)

Event Date 06/23/2015

Event Type  Injury  

Event Description

It was reported surgeon revised patient's left hip due to feeling like implants are loose and feeling unstable.Surgeon did not make any comments intra operatively about any devices being loose but replaced head and liner.

Manufacturer Narrative

Device description reported as unknown size 42 series 1 liner with 10 degree hood.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.

Manufacturer Narrative

The reported event regarding instability of the liner was confirmed.A visual, functional and dimensional inspection could not be performed as the device was not returned as it remains implanted.A complaint history review could not be performed as the device was not properly identified.Clinician review: insufficient medical records were provided for review.The consulting clinician commented that the left acetabular liner was worn of the provided x-ray.It is likely the acetabular wear caused the patient's instability.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported surgeon revised patient's left hip due to feeling like implants are loose and feeling unstable.Surgeon did not make any comments intra operatively about any devices being loose but replaced head and liner.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4921838
• MDR Text Key: 6010656
• Report Number: 0002249697-2015-02364
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2015

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: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 07/17/2015
• 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): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 54