MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM +4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-228
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.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.Should additional information become available it will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient's right hip was revised due to wear of the metal femoral head.Surgeon reported that he suspected that ceramic shards remained in the patient from a 2016 revision (pi (b)(4)) which contributed to the wear.Black tissue was noted intra-operatively.The patient's mdm/ adm liner construct and 28 +4 lfit femoral head were revised to a 44g liner and 44mm biolox head with +4 sleeve.Rep provided intra-operative pictures, explant pictures, and the revision usage sheet.The rep may be able to obtain additional information, but the explants are not available for return.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a metal head was reported.The event was confirmed by provided intraoperative picture and medical review.Method & results: product evaluation and results: the photographs note the following:the reported device was not returned however intra-operative photographs were provided for review.Black tissue was presented.The explanted femoral head was cleaned and appears to be significantly worn.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: retained ceramic debris in and around the hip joint space after a ceramic bearing fracture with revision in (b)(6) 2016, has contributed to excessive and premature third-body wear in the new mdm x3 poly with cochr femoral head requiring a second hip revision surgery in (b)(6) 2018 with exchange of the mdm bearing and femoral head.No device-related factors are associated with any of the implanted devices.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the metal femoral head was excessively worn, which is confirmed by the provided intra-operative picture.The medical review revealed that retained ceramic debris in and around the hip joint space after a ceramic bearing fracture with revision in (b)(6) 2016, has contributed to excessive and premature third-body wear in the new mdm x3 poly with cochr femoral head requiring a second hip revision surgery in (b)(6) 2018 with exchange of the mdm bearing and femoral head.No device-related factors are associated with any of the implanted devices.No further investigation for this event is required at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right hip was revised due to wear of the metal femoral head.Surgeon reported that he suspected that ceramic shards remained in the patient from a 2016 revision ((b)(4)) which contributed to the wear.Black tissue was noted intra-operatively.The patient's mdm/ adm liner construct and 28 +4 lfit femoral head were revised to a 44g liner and 44mm biolox head with +4 sleeve.Rep provided intra-operative pictures, explant pictures, and the revision usage sheet.The rep may be able to obtain additional information, but the explants are not available for return.

• Brand Name: 28MM +4 LFIT V40 HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8966869
• Report Number: 0002249697-2019-03119
• Device Sequence Number: 11284761
• Product Code: JDI
• UDI-Device Identifier: 07613327013061
• UDI-Public: 07613327013061
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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: 07/31/2019
• Device Catalogue Number: 6260-9-228
• Device Lot Number: 48546301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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
• Patient Age: 58 YR