MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 23MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-023; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-1-023
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/22/2018
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 events for the lot referenced.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.Not returned.
Event or Problem Description
Restoration mod proximal body sheared off at the trunnion.Affected implant was removed and replaced with appropriate prox body and mdm head/insert.
Additional Manufacturer Narrative
An event regarding revision due to fracture of a restoration modular - proximal body was reported.The event was confirmed based on the photograph of the device that was provided.Method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted restoration modular body that is fractured at the junction between the body and the taper.Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: this patient had a fracture of a restoration modular cone body.There is no evidence that patient or procedural factors contributed to this.The provided films show no evidence of corrosion and based on the location of the implant fracture i do not believe impingement could have played a role.The trunion and femoral head had not been disengaged so i cannot confirm with absolute certainty there is no corrosive debris.The proximal femoral bone including the greater and lesser trochanters as well as the shaft around the conical stem are all intact making significant trauma less likely.The junction of the conical stem and cone body appears intact on plain film.Based on available information i believe there was a shearing type fracture of the device at the junction of the neck and body.With that said, it would be beneficial to know for sure if the patient sustained any trauma that may have contributed.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the fracture of the restoration modular body at the junction between the body and the taper was confirmed based on the photograph of the device that was provided.Clinician review of the provided medical records indicated: this patient had a fracture of a restoration modular cone body.There is no evidence that patient or procedural factors contributed to this.The provided films show no evidence of corrosion and based on the location of the implant fracture i do not believe impingement could have played a role.The trunion and femoral head had not been disengaged so i cannot confirm with absolute certainty there is no corrosive debris.The proximal femoral bone including the greater and lesser trochanters as well as the shaft around the conical stem are all intact making significant trauma less likely.The junction of the conical stem and cone body appears intact on plain film.Based on available information i believe there was a shearing type fracture of the device at the junction of the neck and body.With that said, it would be beneficial to know for sure if the patient sustained any trauma that may have contributed.Further information regarding the patient history and device evaluation are required to further investigate this event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Restoration mod proximal body sheared off at the trunion.Affected implant was removed and replaced with appropriate prox body and mdm head/insert.

• Brand Name: 23MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-023
• 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: 7610530
• Report Number: 0002249697-2018-01828
• Device Sequence Number: 176257
• Product Code: LPH
• UDI-Device Identifier: 04546540641083
• UDI-Public: 04546540641083
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

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: 11/30/2020
• Device Catalogue Number: 6276-1-023
• Device Lot Number: 53345104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 08/29/2018
• 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: 64 YR
• Patient Weight: 122