MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL POROUS WITH CLUSTER HOLES 54 MM O.D.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Reaction (2414); Osteopenia/ Osteoporosis (2651)
Date of Event	09/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00801803601 ¿ cocr head ¿ 63531216, 00771100520 ¿ m/l taper stem -62107673, 00630505036 ¿ xlpe liner ¿ 63357502.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2020-00172, 0001822565-2020-01282.
Event or Problem Description
It was reported that patient a left hip revision approximately 10 months post implantation due to severe pain.The patient was noted to have very poor bone quality.During the revision procedure, the acetabular shell was noted to be loose with inadequate osseointegration.One of the screws was noted to have pulled through the shell.Metallosis was debrided from the joint and the head, liner and shell components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6.Reported event was confirmed by review of medical records noting patient was revised due to pain.During the procedure, metallosis was noted on the back border of the greater trochanter near the sutures.Clear yellow fluid with some metal debris was present.The acetabulum was found to be loose with only fibrous ingrowth and no bony ingrowth.One of the competitor¿s bone screws had passed through the cup.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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: SHELL POROUS WITH CLUSTER HOLES 54 MM O.D.
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 9937842
• Report Number: 0002648920-2020-00223
• Device Sequence Number: 13628476
• Product Code: LPH
• UDI-Device Identifier: 00889024144712
• UDI-Public: (01)00889024144712
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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 Expiration Date: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 00620005422
• Device Lot Number: 63295722
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 07/31/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention