MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACETABULAR REAMER 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2102-0456

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reamer baskets are dull.Surgeon had difficulty resecting bone.Total hip arthroplasty case delayed for 5 minutes.

Manufacturer Narrative

D10 and h3 corrected to reflect that device was not received for evaluation.Gtin added.An event regarding wear involving a cutting edge reamer was reported.The event was not confirmed.Method & results: -device evaluation and results: the device was received on-site.However, the devices were not transferred to the complaint handling team because appropriate labelling/complaint information was not indicated on the package.Therefore, material, visual, dimensional and functional analysis could not be performed.-medical records received and evaluation: no patient medical records were available for review.-device history review: not performed as lot code information was not provided.-complaint history review: not performed as lot code information was not provided.Conclusion: it was reported that the reamer was not removing bone easily.The event could not be confirmed nor was the supplier was notified as the device was not returned for evaluation.Further information such as product identification and product evaluation are needed to complete the investigation for determining a root cause.If additional information and/or device becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Reamer baskets are dull.Surgeon had difficulty resecting bone.Total hip arthroplasty case delayed for 5 minutes.

• Brand Name: ACETABULAR REAMER 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7202439
• MDR Text Key: 97878351
• Report Number: 0002249697-2018-00190
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K161569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

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: 2102-0456
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/17/2018
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other