MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 40/0, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: item# 00885101340, lot# 63599109, neutral liner 40 mm i.D.Size ll for use with 58 mm o.D.Size ll shell.Item# 00771101210, lot# 63722877, femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 12.5 standard offset reduced neck length.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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).

Event Description

It was reported patient is experiencing pain post implantation.Attempts were made to obtain additional information; however, none was available.

Event Description

Investigation has been completed.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that the products were implanted in the revision surgery on (b)(6) 2017 and since then, the patient has been experiencing on-going pain around the hip and is seeing a pain specialist.Patient had a medical intervention on the (b)(6) 2018 due to pain, whereby the procedure performed was a left total hip aspiration under fluoroscopic guidance.Patient is currently undergoing testing for possible allergies to metals.Review of received data: medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient data: patient found to be obese (bmi 33.78).Significant past medical history: oa, cancer/tumor, fibromyalgia, gout, fibromyalgia, heart attack (bypass x3 2001); right knee 1989 & 2006; left knee 1994 & 1998; neck 1989.Implantation surgical report: 27 oct 2017 left tha revision, acute infection stage i: 35-36 cultures positive- handwritten progress note (pan sensitive staph), lab report ¿ rare gram.Positive cocci, staph aureus.Notes inr slowly coming down despite the vitamin k being given.Access to the femur was difficult due to increased swelling of tissue.Tamp used, unable to remove head from morse taper, additional unplanned procedure to remove stem was performed.Extensive cleaning of cup was performed after liner was explanted.(b)(6) 2017 discharge summary: 37-66: iv vancomycin & rifampoin.Drain removed, picc line placed.Afebrile, wbc wnl.Placed on 325mg ec aspirin, due to concern with medication dosing with coumadin previously.Lab- mssa nasal swab positive.Nov-dec 2017 follow up office visits:37-77.Office visits, plan for 6 weeks iv antibiotics.Patient complains of spasms and pain, eager to start back in physical therapy (b)(6) 2018 left hip aspiration performed under fluoro: pgs.78-79.Performed due to pain left hip.10ml of serous fluid aspirated ¿ sent for alpha defensin testing utilizing zimmer synovasure kit.No results provided.It is assumend that the aspiration is being used as diagnostic tool.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.No revision surgery took place.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check of the known products was performed and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the products were implanted in the revision surgery on (b)(6) 2017 and since then, the patient has been experiencing on-going pain around the hip and is seeing a pain specialist.Patient had a medical intervention on (b)(6) 2018 due to pain, whereby the procedure performed was a left total hip aspiration under fluoroscopic guidance.Patient is currently undergoing testing for possible allergies to metals.Pain cannot be related to a single specific failure mode.Therefore no root cause can be determined.To what extent the patient's medical history might have contributed to the reported event cannot be determined.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 40/0, TAPER 12/14
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10100566
• MDR Text Key: 194657981
• Report Number: 0009613350-2020-00229
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430402
• UDI-Public: 00889024430402
• Combination Product (y/n): N
• PMA/PMN Number: K071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00877504002
• Device Lot Number: 2875878
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Weight: 110