MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ANATO STEM SZ 6 LEFT NEUT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	4845-7-216
Medical Device Problem Codes	Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923); Scratched Material (3020)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374); Inadequate Osseointegration (2646)
Date of Event	11/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that patient's left hip was revised.Patient reported a dislocation, surgeon had planned to swap out liner for mdm but while removing ceramic head from stem the stem came loose.Also, surgeon noticed a roughened articular surface on the poly liner and thought it was out of the ordinary.
Additional Manufacturer Narrative
An event regarding loosening involving an anato stem was reported.The event was not confirmed.Method & results: device evaluation and results: a material analysis has been performed.The report concluded: ¿scratching was observed on along the body of the hip stem.A continuous metal transfer ring was observed on the internal circumference of the female taper consistent with proper seating between of the trunnion of the hip stem and the head taper.Scratching, pitting and embedded debris were observed on the surfaces of the trident insert.Eds showed that the hip stem was consistent with astm f136 and the adhered debris on the trident insert was consistent with a bone fragment.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined." medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the material analysis reported concluded that "scratching was observed on along the body of the hip stem.A continuous metal transfer ring was observed on the internal circumference of the female taper consistent with proper seating between of the trunnion of the hip stem and the head taper.Scratching, pitting and embedded debris were observed on the surfaces of the trident insert.Eds showed that the hip stem was consistent with astm f136 and the adhered debris on the trident insert was consistent with a bone fragment.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined." therefore the event of stem loosening was not confirmed.Further information such as patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
It was reported that patient's left hip was revised.Patient reported a dislocation, surgeon had planned to swap out liner for mdm but while removing ceramic head from stem the stem came loose.Also, surgeon noticed a roughened articular surface on the poly liner and thought it was out of the ordinary.

• Brand Name: ANATO STEM SZ 6 LEFT NEUT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7105078
• Report Number: 0002249697-2017-03548
• Device Sequence Number: 13818499
• Product Code: LPH
• UDI-Device Identifier: 07613252631330
• UDI-Public: 07613252631330
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2022
• Device Catalogue Number: 4845-7-216
• Device Lot Number: 58371909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR