MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL, 32/+7, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
Patient was implanted on right side and underwent revision surgery due to joint instability.Stem, insert and head were revised.
Event or Problem Description
No event update.Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.Additional: h2, h6.Correction: b4, b5, g4, g7, h10.Review of event description: it was reported that the patient underwent right hip replacement on (b)(6) 2020.Subsequently, on (b)(6) 2020 the stem, insert and head were revised due to joint instability.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.Incident report (b)(4): manufacturers: ceramic insert from adler ortho - ref#(b)(4), 46/48x32mm.Wagner stem from zimmer - (b)(4), 16/125.Biolox delta head from zimmer - (b)(4), 32/+7.Patient data: r.R., 52 years old.Implantation: (b)(6) 2020.Diagnosis: right coxarthrosis on congenital hip dysplasia.Event: revision of the stem, insert and head for joint instability of the prosthesis.Devices available at: repo c/o ior medical technology laboratory.The devices were sent preliminarily to the microbiology laboratory for sonication.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was not approved by zimmer biomet, because the wagner stem and the biolox head were combined with a ceramic insert from a different manufacturer.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the patient underwent a right hip replacement on (b)(6) 2020.Subsequently, on (b)(6) 2020, the stem, insert, and head were revised due to joint instability.Neither medical records (e.G.Operative reports, office visit records, radiographs, etc.), patient data (e.G.Comorbidities) nor the explants were obtained.The reason for the instability (e.G.Implant positioning, loosening, etc.) was not described.The quality records show that all specified characteristics of the wagner stem and the biolox head 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).The reported product combination is not approved by zimmer biomet because a ceramic insert from another manufacturer was used, which is an off-label use.The unauthorized product combination could be a possible cause for the reported joint instability.However, based on the information provided, it was not possible to conduct a detailed investigation.Therefore, we could neither confirm the reported instability nor find a definite cause.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, XL, 32/+7, 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: 10332525
• Report Number: 0009613350-2020-00347
• Device Sequence Number: 3162503
• Product Code: LZO
• UDI-Device Identifier: 00889024430341
• UDI-Public: 00889024430341
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-032-04
• Device Lot Number: 2912988
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 02/12/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR