MAUDE Adverse Event Report: BIOMET UK LTD. RLOC-X ARCOMXL H/W 60/36MM 26; ARCOM XL LINERS HXLPE

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Medical product: exc abt rnglc-x shell pc 058mm, catalog #: 131358, lot #: 3707611.Medical product: sirius hip stem 44-d, catalog #: 51-199341, lot #: 360500.Medical product: 36mm cocr mod hd -6mm, catalog #: 11-363660, lot #: 518020.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00062.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient participating in clinical study, had a left primary tha performed on (b)(6) 2015.Subsequently, the patient experienced pain on the left thigh at night, with suspicion of trochanter bursitis.The patient received 2 blocks with only short term relief.The first was received on (b)(6) 2020 and second on (b)(6) 2021.

Manufacturer Narrative

This follow-up report is being submitted to make corrections and relay additional information.D11: medical product: rloc-x arcomxl h/w 60/36mm 26, catalog #: xl-053660, lot #: 3541789.Medical product: sirius hip stem 44-d, catalog #: 51-199341, lot #: 877720.Medical product: 36mm cocr mod hd std, catalog #: 11-363662, lot #: 052670.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00062-1.Additional information received: race: caucasian, dob / age: 1941/75 years, height: 171cm, bmi: 28.73.Corrections: a review of (b)(4) has established that the incorrect product numbers have been previously reported.The correct products have been identified on page 21 of the clinical study.The complaint has been updated accordingly: item #131360 lot #3565171 item name: exc abt rnglc-x shell pc 060mm.Item #xl-053660 lot # 3541789 item name: rloc-x arcomxl h/w 60/36mm 26.Associated products: item #51-199341 lot #877720 item name: sirius hip stem 44-d.Item # 11-363662 lot #052670item name: 36mm cocr mod hd std.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that a patient participating in clinical study, had a left primary tha performed on (b)(6) 2015.Subsequently, the patient experienced pain on the left thigh at night, with suspicion of trochanter bursitis.The patient received 2 blocks with only short term relief.The first was received on (b)(6) 2020 and second on (b)(6) 2021.The patient is fit and can walk up to 10 km without problems.The pain only occurs at night when lying down, therefore the patient was sent to physiotherapist.No revision is planned.

Manufacturer Narrative

This final report is being submitted to make corrections and relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00062-2.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 2 complaints(including initiating complaint) reported with the item 131360 and 2 complaints(including initiating complaint) reported with the item xl-053660.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported that a patient participating in clinical study, had a left primary tha performed on (b)(6) 2015.Subsequently, the patient experienced pain on the left thigh at night, with suspicion of trochanter bursitis.The patient received 2 blocks with only short term relief.The first was received on (b)(6) 2020 and second on (b)(6) 2021.The patient is fit and can walk up to 10 km without problems.The pain only occurs at night when lying down, therefore the patient was sent to physiotherapist.No revision is planned.

• Brand Name: RLOC-X ARCOMXL H/W 60/36MM 26
• Type of Device: ARCOM XL LINERS HXLPE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11391971
• MDR Text Key: 234002428
• Report Number: 3002806535-2021-00063
• Device Sequence Number: 1
• Product Code: LPH
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: XL-053660
• Device Lot Number: 3541789
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 82