MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 40/+3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products according: item: wagner sl revision hip stem, catalog #: 01.00102.215, lot #: 2949504; item: cable cerclage cable, catalog #: 00223200418, lot #: 63694569; item: cable cerclage cable, catalog #: 00223200418, lot #: 64230671; item: bone scr 6.5x30 self-tap, catalog #: 00625006530, lot #: 64143367; item: bone scr 6.5x20 self-tap, catalog #: 00625006520, lot #: 64179978; item: bone scr 6.5x35 self-tap, catalog #: 00625006535, lot #: 64190169; item: bone scr 6.5x35 self-tap, catalog #: 00625006535, lot #: 64190171; item: bone scr 6.5x20 self-tap, catalog #: 00625006520, lot #: 64857661; item: bone scr 6.5x30 self-tap, catalog #: 00625006530, lot #: 64199626; item: extended 4 hole gtr w/4 cables, catalog #: 00223200206, lot #: 56693784; item: full blade, catalog #: 00705306220 , lot #: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The manufacturer did not receive x-rays, or other source documents for review.The device history records were reviewed and found to be conforming.An e-mail requesting the following additional information was sent on february 07, 2019 to the appropriate representatives: revision report; all available x-rays during time in- vivo with printed date; all available intraoperative pictures.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350 -2019 - 00077.The following reports are associated with this event (same patient): (b)(4) - revision surgery.(b)(4) - trochanter fracture and further fragmentation during surgery.(b)(4) - revision due to unknown traumatic event during rehab.(b)(4) - liner did not seat properly upon impaction.
Event or Problem Description
It was reported that a patient underwent a revision surgery due to unknown reason.Note: at the moment it is unknown whether or what type of device have been explanted during this revision surgery.Information has been requested.
Event or Problem Description
Please refer to report 0009613350-2019-00078.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: analysis could not be performed as no specific event information is available.Event description: it was reported that patient had underwent initial hip surgery in 2002.The patient was revised on (b)(6) 2019 due to pain, recurring dislocations, and elevated cobalt and chromium levels.Subsequently, the patient was revised again on (b)(6) 2019 due to an unknown traumatic event that occurred during rehab.Review of received data: op notes dated (b)(6) 2019 confirm that the patient underwent a revision surgery.Notes demonstrated that surgeon observed metallosis, staining and damage of tissue, synovial fluid dark colored, and corrosion of the femoral neck junction.Surgeon also reported extensive osteolysis of femur and bone loss of the acetabulum.During the attempt to remove a well fixed stem, it was noted the greater trochanter fractured along with fragmentation while performing the trochanter osteotomy.New implants were inserted, reduced and hip was found stable.The op notes for (b)(6) 2019 revision was not provided.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all involved devices are intended for treatment.Surgical technique of the wagner stem is not reviewed as no specific event information is available.Conclusion: patient underwent revision surgery 2 weeks post-op due to an unknown event where the liner of the thr is revised.Stem and head (winterthur design products) were kept in.Review of the device history record identified no deviations or anomalies would contribute to reported event.The investigation results did not identify a non-conformance or a complaint out of box (coob).Due to significant lack of information, it is impossible to perform a meaningful analysis of the event.Most likely cause of the reported event could possibly be the traumatic event that the patient experienced.Based on the given information the complaint could not be confirmed and no root cause could be identified.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event (same patient): - (b)(4) - revision surgery.- (b)(4) - trochanter fracture and further fragmentation during surgery.- (b)(4) - revision due to unknown traumatic event during rehab.- (b)(4) - liner did not seat properly upon impaction.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 40/+3.5, TAPER 12/14
• Common Device Name: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8349659
• Report Number: 0009613350-2019-00078
• Device Sequence Number: 13504399
• Product Code: LZO
• UDI-Device Identifier: 00889024430419
• UDI-Public: 00889024430419
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-040-03
• Device Lot Number: 2955280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 07/25/2019
• 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
• Patient Age: 36 YR
• Patient Weight: 107