MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM; IMPLANT

Catalog Number 502-03-50D

Device Problems Sticking (1597); Fitting Problem (2183); No Apparent Adverse Event (3189)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2015

Event Type  malfunction  

Event Description

During a primary hip surgery, surgeon was using the curved impactor to seat the cup.During the process the bolt got stuck in the cup and as a result the cup had to be removed as cup was well fixed but due to bolt sticking in cup, a new cup had to be implanted.Approximately a 10 minute delay in surgery as a result as a new cup had to be opened and the surgical site re-reamed.Correction per sales rep: surgical site did not have to be re-reamed.Only took out the first cup and put in new cup.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

Conclusion: this event is related to a series of similar reported events where the impactor bolt cannot be dissociated from the associated shell.A capa was raised to further investigate these events.The preliminary investigation shows these events are associated with a wide variety of shells.Therefore, the impactor bolt will be further investigated.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

During a primary hip surgery, surgeon was using the curved impactor to seat the cup.During the process the bolt got stuck in the cup and as a result the cup had to be removed as cup was well fixed but due to bolt sticking in cup, a new cup had to be implanted.Approximately a 10 minute delay in surgery as a result as a new cup had to be opened and the surgical site re-reamed.Correction per sales rep: surgical site did not have to be re-reamed.Only took out the first cup and put in new cup.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM
• 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: 4888308
• MDR Text Key: 6069941
• Report Number: 0002249697-2015-02184
• Device Sequence Number: 1
• Product Code: LPH
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 502-03-50D
• Device Lot Number: W64V8K
• Other Device ID Number: STER. LOT MSHPJ12A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 07/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2015
• 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