MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACE SHELL-CLUST HOLE POR-58MM IMPLANT; HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE

Catalog Number 186002-58

Device Problems Device Operates Differently Than Expected (2913); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2015

Event Type  malfunction  

Event Description

Surgeon reamed and impacted.Needed more fixation/screws.Converted to stryker multi-hole.The only issue was poor fixation which requires additional screws.

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown 58 mako cup.Additional information was requested and if it becomes available will be submitted in a supplemental report.Not returned to manufacturer.

Manufacturer Narrative

The event reported does not represent a complaint.It was reported the surgeon felt better fixation could be achieved with more than 3 screws.As the reported product only has 3 screw holes, the surgeon elected to use a different cup.No device deficiencies were reported.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.

Event Description

Surgeon reamed and impacted.Needed more fixation/screws.Converted to stryker multi-hole.The only issue was poor fixation which requires additional screws.

• Brand Name: ACE SHELL-CLUST HOLE POR-58MM IMPLANT
• Type of Device: HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4765099
• MDR Text Key: 5785677
• Report Number: 3005985723-2015-00072
• Device Sequence Number: 1
• Product Code: OQI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

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 Catalogue Number: 186002-58
• Device Lot Number: 030987-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2015
• 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): Other