MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 27MM MOD REV HIP BDY/BLT +30MMCOMPONENT LEVEL 9006-1-327; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-1-327
Medical Device Problem Codes	Mechanical Problem (1384); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Loss of Range of Motion (2032); Injury (2348); Joint Dislocation (2374)
Date of Event	08/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other 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.Conclusion of assessment; presence of extensive heterotopic ossifications close to the arthroplasty with likely bony impingement problems in an elderly patient with previous extensive hip revision surgery and thus associated high instability risk has contributed to an overload condition in the arthroplasty with dislocation requiring revision surgery.Patient related factors identified that contributed to the event; extensive heterotopic ossifications close to the arthroplasty (brooker grade-3) with likely bony impingement.Higher patient age ((b)(6)) also carries an increased hip instability risk device related factors that caused or contributed to the adverse event; no device-related factors are associated with any of the implanted devices.Device not returned.
Event or Problem Description
It was reported that patient's right hip was revised due to dislocation of the stryker head from a competitor liner.Patient was revised to another competitor liner and a biolox delta ceramic head.Update 07 sep 2018: a review by a clinical consultant has identified range of motion issues (bony impingement) and instability.

• Brand Name: 27MM MOD REV HIP BDY/BLT +30MMCOMPONENT LEVEL 9006-1-327
• 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: 7938236
• Report Number: 0002249697-2018-03221
• Device Sequence Number: 16482699
• Product Code: LPH
• UDI-Device Identifier: 07613154057948
• UDI-Public: 07613154057948
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

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: 06/30/2016
• Device Catalogue Number: 6276-1-327
• Device Lot Number: 37007301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 10/05/2018
• 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: 76 YR