MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 23MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-023

Catalog Number	6276-1-023
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	08/27/2019
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 relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
Patient presented with lysis.Loose at the body stem interface.Revision of cone conical restoration modular stem.Left tha.Update: "the reason for revision was pt pain and lysis on scans.The surgeon hypothesised that it may have been a loose stem/ body interface.".

• Brand Name: 23MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-023
• Common Device Name: 23MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-023
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9111368
• Report Number: 0002249697-2019-03322
• Device Sequence Number: 3041787
• Product Code: LPH
• UDI-Device Identifier: 04546540641083
• UDI-Public: 04546540641083
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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: 04/30/2012
• Device Catalogue Number: 6276-1-023
• Device Lot Number: 22421101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/24/2019
• 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