MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS 5CM DIAPHYSEAL SEGMENT; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2020-03479.Medical product: oss cemented im stem 15x150 item# 150369 lot# 613330.Oss 5cm diaphyseal segment item# 150465 lot# 925300.Oss poly femoral bushings item# 150477 lot# 742240.Oss tibial poly bearing 14mm item# 150411 lot# 560730.Foreign report source: (b)(6).Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient was revised approximately one year and seven months¿ post implantation due to early aseptic loosening of the femoral stem.There is no additional information at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: d11.D11- medical product.Oss 7cm segmental femoral rt, item# 150354, lot# 804700.The product that is being reported has been changed from the oss 7cm segmental femoral rt to oss 5cm diaphyseal segment as that is actually the product associated with the femoral loosening.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.D11- medical product oss cemented im stem 15x150 , item# 150369 , lot# 613330, oss 5cm diaphyseal segment ,item# 150465 lot# 925300, oss poly femoral bushings, item# 150477 lot# 742240, oss tibial poly bearing 14mm, item# 150411 lot# 560730, oss poly tibial bushing , item# 150476 lot# 315070, oss poly lock pin, item# 150478 lot# 668620, oss poly femoral bushings, item# 150477 lot# 742240, oss axle , item# 150480, lot# ,258450, oss reinforced yoke, item# 150493, lot# 061560, optip 60 refob plus bone cmt-3 item# 4721502084-3 lot# 807ba06965.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, g4, g5, g7, h1, h2, h3, h6, and h10.Visual examination of the returned product found signs of being implanted (scratches and foreign material).Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OSS 5CM DIAPHYSEAL SEGMENT
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10511967
• Report Number: 0001825034-2020-03478
• Device Sequence Number: 11599260
• Product Code: JDI
• UDI-Device Identifier: 00880304238824
• UDI-Public: (01)00880304238824
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K123501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 150465
• Device Lot Number: 925300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 09/22/2020; 12/10/2020; 01/21/2021
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/06/2020; 12/28/2020; 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; SEE H10.; SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR