MAUDE Adverse Event Report: ZIMMER GMBH COCR LINER HIP; N/A

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Medical products and therapy date.Detail of product: item # unknown.Item name biolox head hip.Lot # unknown.The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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 Description

It was reported that patient underwent revision surgery due to infection after unknown time form the implantation.

Manufacturer Narrative

Event description: it was reported that the patient received an implant on unknown date and was revised on (b)(6) 2014 due to infection.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.Maude report: implant date: (b)(6) 2014 (explant date for previously implanted components due to infection) event description: the patient had his left stryker rejuvenate hip revised due to infection.Explant was stryker rejuvenate stem size 7 and a 28mm +0 biolox head, size 56 adm cup with cocr component.In 2013 prior to revision of the rejuvenate implant the patient's serum/plasma cobalt level was 15 mcg/l.No medical records have been received.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 could not be performed due to missing product identification.Dhr review: review of the device history records could not be reviewed due to lack of product identification.Conclusion: it was reported that the patient received an implant on unknown date and was revised on (b)(6) 2014 due to infection.Based on the maude event description it remains unknown if a zimmer biomet device was involved in the reported event, as other manufacturers' portfolio also contain biolox heads.Therefore, based on the significant lack of information the reported event could neither be confirmed nor could an in-depth investigation be performed.At this point, there is no indication of a non-conformance or complaint out of box (coob).Since this case is related to the issues for which zimmer implemented a corrective action there will be no further investigation.Zimmer¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2020-00201, 0009613350-2020-00200.

Event Description

No change to previously reported event.

• Brand Name: COCR LINER HIP
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9985639
• MDR Text Key: 193434747
• Report Number: 0009613350-2020-00201
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention