MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN HEAD; HIP IMPLANT

Catalog Number UNK_JR

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that patient's right hip was revised due to the head and neck shearing off of the stem.

Event Description

It was reported that patient's right hip was revised due to the head and neck shearing off of the stem.

Manufacturer Narrative

An event regarding stem neck fracture involving an accolade stem was reported.The event was not confirmed.Based on the information provided there is no indication or allegation that device reported in this investigation may have contributed to the event.Based on the information provided, the unknown head did not contribute to the fracture of the stem.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Manufacturer Narrative

An event regarding stem neck fracture involving an accolade stem was reported.The event was not confirmed.Based on the information provided, the unknown head did not contribute to the fracture of the stem.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before (b)(6) 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.

Event Description

It was reported that patient's right hip was revised due to the head and neck shearing off of the stem.

• Brand Name: UNKNOWN HEAD
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7147972
• MDR Text Key: 95827885
• Report Number: 0002249697-2017-03692
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 01/12/2018; 05/04/2018
• Supplement Dates FDA Received: 02/09/2018; 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2249697-05-07-2018-003-R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR