MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 28/-3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products and therapy date detail of product: item number 110024462, item name g7 dual mobility liner 40mm d, lot # 359580.Item number ep-200146, item name act artic e1 hip brg 28x40mm s46 dia28, lot # 820680.Item number 010000662, item name g7 pps ltd acet shell 50d, lot # 6387774.Item number 00786401300, item name femoral stem press-fit collarless 12/14 neck taper standard body standard neck offset size 13 138 mm stem length cementless, lot # 64052372.The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device for investigation.Attempts to obtain additional information have been made; however, no more is 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.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
It was reported that patient underwent revision surgery due to dislocation.
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Event summary: it was reported that the patient has been implanted with the biolox head on apr 4, 2019 and underwent revision on dec 3, 2019 due to dislocation.Review of received data implant and explant reports were received and it was found that the patient had implant surgery on (b)(6) 2019 due to femoral neck fracture.In the interim patient had a stroke and had a deformity in right lower extremity.Patient had been treated with closed reduction which has failed and lead to revision surgery.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Conclusion summary: it was reported that the patient has been implanted with the biolox head on (b)(6) 2019 and underwent revision on (b)(6) 2019 due to dislocation.In vivo time of the device 8 months.Patient underwent closed reduction by (b)(6), md on (b)(6) 2019, which was not successful.Patient recently suffered a stroke.Patient was walking without pain and functioning well up until that point.Patient's daughters noted following a stroke at some point that the patient stopped walking and complained of hip pain.Patient could not provide accurate history, either related to the performance of the hip replacement up until the revision surgery or an episode resulting in dislocation.Daughters also could not provide any additional insight, stating that the patient may perhaps have fallen at her rehab facility where she had been discharged following the stroke.The investigation results did not identify a non-conformance or a complaint out of box (coob).Based on the available information, we were not able to identify an exact root cause for this issue.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).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 28/-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: 9557613
• Report Number: 0009613350-2020-00015
• Device Sequence Number: 11348206
• Product Code: LZO
• UDI-Device Identifier: 00889024430280
• UDI-Public: 00889024430280
• 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
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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: 00-8775-028-01
• Device Lot Number: 2962146
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 03/27/2020
• 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 Weight: 63