MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 36MM; IMPLANT

Catalog Number 623-00-36D

Device Problems Unstable (1667); No Apparent Adverse Event (3189)

Patient Problems Weakness (2145); Ambulation Difficulties (2544)

Event Date 09/18/2013

Event Type  Injury  

Event Description

Patient suffered from instability of the operated hip.

Manufacturer Narrative

Other devices listed in this report: cat.No.: 7849-1-050d; trident(tm) tc.Threaded cup; lot code: g2151278.Cat.No.: 7850-1-002; hipstar v40 stem n ø2; lot code: g2083685.Cat.No.: 6565-0-136; alumina v40-femoral head 36mm, +0mm nk; lot code: 25515001.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.

Manufacturer Narrative

An event regarding loosening involving a hipstar stem was reported.Conclusion: based on the provided information, the product reported in this investigation did not contribute to the event.A review of the provided information by a clinical consultant indicated, "this case relates to stem loosening as evident by the very brief revision surgery report." there is no allegation of failure against the trident liner.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient suffered from instability of the operated hip.

• Brand Name: TRIDENT 0 DEG INSERT 36MM
• 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: 4892685
• MDR Text Key: 6535709
• Report Number: 0002249697-2015-02197
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2015

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 Expiration Date: 04/30/2012
• Device Catalogue Number: 623-00-36D
• Device Lot Number: 33RMHD
• Other Device ID Number: STERILE LOT# MG0704I053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2007
• 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: 59 YR
• Patient Weight: 80