MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 32/+3.5, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: shell with cluster holes porous 52 mm o.D.Size ii for use with ii liners; item#00875705201; lot#64531042; bone screw self-tapping 6.5 mm dia.35 mm length; item#00625006535; lot#j6684866; bone screw self-tapping 6.5 mm dia.20 mm length; item#00625006520; lot#62963992; femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 7.5 standard offset; item#00771100700; lot#64232501; elevated rim liner 32 mm i.D.Size ii for use with 52 mm o.D.Size ii shell; item#00885201032; lot#64030974.X-rays and other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.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 the right side and underwent revision due to pain, dislocation, subluxation and noise.
Event or Problem Description
Investigation result is available now.
Additional Manufacturer Narrative
Investigation results were made available.Event description: it was reported that the patient had initial right tha on (b)(6) 2020.Subsequently, the patient experienced a first anterior dislocation which was reduced in the or on (b)(6) 2020 (covered in (b)(4)).On (b)(6) 2020 the patient dislocated again and underwent reduction.One day later, on (b)(6) 2020 the patient underwent revision due to subluxation, dislocation, pain, impingement, and noise (clicking), which is covered in this complaint.Review of received data: review of medical records: medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a right total hip arthroplasty on (b)(6) 2020 due to osteoarthritis.Zimmer biomet components were implanted without complications.Office notes dated (b)(6) 2020 state the patient dislocated the right hip again when she was in bed and rolled over with her knee flexed.Another closed reduction procedure was performed.Revision notes dated (b)(6) 2020 state impingement on the elevated poly liner with anterior dislocation.There is a very palpable click as the hip dislocates.The liner and the head were removed and replaced with new zimmer biomet products.No other complication/findings related to the event were noted.Review of the radiographs identified the patient's bone quality was osteopenic.Patient data: k.N-b., female, born (b)(6) 1977.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.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 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 patient had initial right tha on (b)(6) 2020.Subsequently, the patient experienced a first anterior dislocation which was reduced in the or on (b)(6) 2020 (covered in (b)(4)).On (b)(6) 2020 the patient dislocated again and underwent reduction.One day later, on (b)(6) 2020 the patient underwent revision due to subluxation, dislocation, pain, impingement, and noise (clicking), which is covered in this complaint.Based on the revision report it can be assumed that the elevated insert together with alignment and orientation of the shell and the stem led to the mentioned impingement leading to dislocation.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 non-conformance or a complaint out of box (coob).Based on the investigation, choice and orientation of the implants chosen for the patient's anatomy during initial right tha are considered the cause for the reported impingement leading to the reported dislocation.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, 32/+3.5, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10166843
• Report Number: 0009613350-2020-00263
• Device Sequence Number: 16682549
• Product Code: LZO
• UDI-Device Identifier: 00889024430334
• UDI-Public: 00889024430334
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-032-03
• Device Lot Number: 3006376
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 12/14/2020
• 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
• Patient Age: 43 YR
• Patient Weight: 78