MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 36/+3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products: liner elevated rim 36 mm i.D.Size ii for use with 52 mm o.D.Size ii shell; catalog#: 00-8752-010-36; lot#: 63200919.Therapy date: unknown.The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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 or Problem Description
The patient underwent a total hip arthroplasty on the right side and post surgery developed a hematoma which needed surgical evacuation.During the surgical evacuation, the head, liner and adapter were revised.
Event or Problem Description
Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.1.Event description: it was reported that the patient was initially implanted with a biolox head on (b)(6) 2016.Subsequently, the patient developed a hematoma, which needed surgical evacuation on an unknown date.During the surgical evacuation, the head, liner and adapter were revised.Harm: s3 - tissue damage, moderate hazardous situation: reported issue is not device related.2.Review of received data: - due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.- journal article a case of titanium pseudotumor and systemic toxicity after total hip arthroplasty polyethylene failure: the journal article describes that a 57-year-old female patient underwent bilateral tha.Both surgeries, performed using a posterior approach 6 months apart, were each complicated by early postoperative hematoma formation requiring hematoma evacuation and revision of modular components, including polyethylene liner exchange and femoral head exchange to ceramic heads with titanium trunnion adapter sleeves [1].The article does not contain further relevant data with respect to the event.- medical data: - post operative note with implant stickers from the initial surgery on (b)(6) 2016 - initial right side op note from (b)(6) 2016 states: a drain was left just above the fascia as the patient had a prior hematoma, which was above the fascia after her last total hip.3.Product evaluation: - no product was returned; therefore, visual evaluation could not be performed.4.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was not approved by zimmer biomet.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.5.Conclusion: it was reported that the patient was initially implanted with a biolox head on (b)(6) 2016.Subsequently, the patient developed a hematoma, which needed surgical evacuation on an unknown date.During the surgical evacuation, the head, liner and adapter were revised.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).It was reported that the patient underwent a head and liner exchange during a surgical hematoma evacuation in an unknown timeframe postop.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure.The development of a postoperative hematoma after a procedure can be correlated with the surgical procedure and perioperative anticoagulation therapy to prevent dvt (prophylaxis).Patients may be at increased risk for developing hematomas if they have received fresh-frozen plasma, vitamin k, or hormonal therapy as well.Most hematomas resolve on their own, without surgical intervention, while some others do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.[1] tarpada sp, loloi j, schwechter em.A case of titanium pseudotumor and systemic toxicity after total hip arthroplasty polyethylene failure.Arthroplasty.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, L, 36/+3.5, TAPER 12/14
• Common Device Name: 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: 12384446
• Report Number: 0009613350-2021-00441
• Device Sequence Number: 4634209
• Product Code: LZO
• UDI-Device Identifier: 00889024430372
• UDI-Public: 00889024430372
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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 Expiration Date: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-03
• Device Lot Number: 2839492
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/29/2021
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR